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BACKGROUND: The purpose of this study is to evaluate the safety and intermediate-term efficacy of percutaneous microwave (MW) ablation for the treatment of colorectal liver metastases (CRLM) at a single institution. METHODS: A retrospective review was performed of all CRLM treated with MW ablation from 3/2011 to 7/2020 (102 tumors; 72 procedures; 57 patients). Mean age was 60 years (range, 36–88) and mean tumor size was 1.8 cm (range, 0.5–5.0 cm). The patient population included 19 patients with extra-hepatic disease. Chemotherapy (pre- and/or post-ablation) was given in 98% of patients. Forty-five sessions were preceded by other focal CRLM treatments including resection, ablation, radiation, and radioembolization. Kaplan-Meier curves were used to estimate local tumor progression-free survival (LTPFS), disease-free survival (DFS), and overall survival (OS) and multivariate analysis (Cox Proportional Hazards model) was used to test predictors of OS. RESULTS: Technical success (complete ablation) was 100% and median follow-up was 42 months (range, 1–112). There was a 4% major complication rate and an overall complication rate of 8%. Local tumor progression (LTP) rate during the entire study period was 4/98 (4%), in which 2 were retreated with MW ablation for a secondary LTP-rate of 2%. LTP-free survival at 1, 3, and 5 years was 93%, 58%, and 39% and median LTP-free survival was 48 months. OS at 1, 3, and 5 years was 96%, 66%, 47% and median OS was 52 months. There were no statistically significant predictors of OS. CONCLUSIONS: MW ablation of hepatic colorectal liver metastases appears safe with excellent local tumor control and prolonged survival compared to historical controls in selected patients. Further comparative studies with other local treatment strategies appear indicated.

To determine whether histotripsy can create human-scale transcostal ablations in porcine liver without causing severe thermal wall injuries along the beam path. Histotripsy was applied to the liver using a preclinical prototype robotic system through a transcostal window in six female swine. A 3.0 cm spherical ablation zone was prescribed. Duration of treatment (75 min) was longer than a prior subcostal treatment study (24 min, 15 s) to minimize beam path heating. Animals then underwent contrast-enhanced MRI, necropsy, and histopathology. Images and tissue were analyzed for ablation zone size, shape, completeness of necrosis, and off-target effects. Ablation zones demonstrated complete necrosis with no viable tissue remaining in 6/6 animals by histopathology. Ablation zone volume was close to prescribed (13.8 ± 1.8 cm3 vs. prescribed 14.1 cm3). Edema was noted in the body wall overlying the ablation on T2 MRI in 5/5 (one animal did not receive MRI), though there was no gross or histologic evidence of injury to the chest wall at necropsy. At gross inspection, lung discoloration in the right lower lobe was present in 5/6 animals (mean size: 1 × 2 × 4 cm) with alveolar hemorrhage, preservation of blood vessels and bronchioles, and minor injuries to pneumocytes noted at histology. Transcostal hepatic histotripsy ablation appears feasible, effective, and no severe injuries were identified in an acute porcine model when prolonged cooling time is added to minimize body wall heating.

BACKGROUND: Previous human-scale porcine liver model studies of histotripsy have resulted in ablation zones elongated in the cranial-caudal (CC) dimension due to uninterrupted respiratory motion during the ablation procedure. PURPOSE: The purpose of this study is to compensate for elongation of hepatic histotripsy ablation zones in the cranial-caudal (CC) dimension caused by respiratory motion by prescribing ellipsoid shaped ablations. METHODS: Six female swine underwent 12 hepatic histotripsy ablations using a prototype clinical histotripsy system under general anesthesia. Each animal received two ablation zones prescribed as either an ellipsoid (2.5cm (AP) x 2.5cm (ML) x 1.7cm (CC), prescribed volume=5.8cc) or a sphere (2.5cm all dimensions, prescribed volume 8.2cc). Ventilatory tidal volume was held constant at 400cc for all ablations. Post procedure MRI was followed by sacrifice and gross and microscopic histology. RESULTS: Ablations on MRI were slightly larger than prescribed in all dimensions. Ellipsoid plan ablations (2.8 × 3.0 × 3.1cm, volume 13.2cc, sphericity index 0.987) were closer to prescribed volume than spherical plan ablations (2.9 × 3.1 × 3.7cm, volume 17.1cc, sphericity index 0.953). Ellipsoid plan ablations were more spherical than sphere plan ablations, but the difference did not reach statistical significance (p=.06). Pathologic analysis confirmed complete necrosis within the center of each ablation zone with no widening of the zone of partial ablation on the superior and inferior as compared to the lateral borders (p=.22). CONCLUSION: Altering ablation zone prescription shape when performing hepatic histotripsy ablations can partially mitigate respiratory motion effects to achieve the desired ablation shape and volume.

Evaluate the safety and efficacy of adrenal microwave ablation performed with continuous intra-arterial blood pressure monitoring (IABPM) and without alpha-adrenergic blockade (AAB) as pretreatment. A single-center, retrospective review of all percutaneous adrenal microwave ablation performed between 2011 and 2018. Microwave ablation was completed on 11 patients, with a total of 15 adrenal tumors with a mean size of 3.3 cm (1.4–6.9 cm) treated metastatic RCC, HCC, esophageal carcinoma, adrenal adenoma. Cases were performed without prior AAB, but with continuous IABPM and rapid intervention using short-acting antihypertensive medications. There were no post-procedural episodes of hypertension, no neurological or cardiovascular complications, and no SIR moderate or worse adverse event complications. Mean intraprocedural maximum systolic blood pressure (SBP) was 211 mmHg (range: 132–288), with an average increase in SBP of 100 mmHg (range: 23–180). A hypertensive crisis (SBP ≥ 180 and/or DBP ≥ 120) occurred in 9 of the 15 procedures (60%) with a mean length of 3.0 min (range: 1–12). The technical success rate was 100% (15/15 procedures). The mean follow-up time was 2.4 years (range: 0.9–7.7 years), with primary and secondary efficacy rates of 77% and 87%, respectively, and an overall survival of 82%. In this single-center retrospective study, microwave ablation of adrenal tumors without AAB was safe and effective when performed with continuous arterial line monitoring of vital signs and the use of short-acting, rapid-onset antihypertensive medications. Level 4, Case Series.

PURPOSE: Robotically assisted sonic therapy (RAST) is a nonthermal, noninvasive ablation method based on histotripsy. Prior animal studies have demonstrated the ability to create hepatic ablation zones at the focal point of an ultrasound therapy transducer; however, these treatments resulted in thermal damage to the body wall within the path of ultrasound energy delivery. The purpose of this study was to evaluate the efficacy and safety of a pulse sequence intended to mitigate prefocal body wall injury. MATERIALS AND METHODS: Healthy swine (n = 6) underwent hepatic RAST (VortxRx software version 1.0.1.3, HistoSonics, Ann Arbor MI) in the right hepatic lobe. A 3.0 cm spherical ablation zone was prescribed for each. Following treatment, animals underwent MRI which was utilized for ablation zone measurement, evaluation of prefocal injury, and assessment of complications. Each animal was euthanized, underwent necropsy, and the tissue was processed for histopathologic analysis of the ablation zone and any other sites concerning for injury. RESULTS: No prefocal injury was identified by MRI or necropsy in the body wall or tissues overlying the liver. Ablation zones demonstrated uniform cell destruction, were nearly spherical (sphericity index = 0.988), and corresponded closely to the prescribed size (3.0 9 3.1 9 3.4 cm, p = 0.70, 0.36, and 0.01, respectively). Ablation zones were associated with portal vein (n = 3, one occlusive) and hepatic vein thrombosis (n = 4, one occlusive); however, bile ducts remained patent within ablation zones (n = 2). CONCLUSIONS: Hepatic RAST performed with a modified ultrasound pulse sequence in a porcine model can mitigate prefocal body wall injuries while maintaining treatment efficacy. Further study of hepatic RAST appears warranted, particularly in tumor models.

Purpose To demonstrate the feasibility of Robotically Assisted Sonic Therapy (RAST)—a noninvasive and nonthermal focused ultrasound therapy based on histotripsy—for renal ablation in a live porcine model. Materials and Methods RAST ablations (n = 11) were performed in 7 female swine: 3 evaluated at 1 week (acute) and 4 evaluated at 4 weeks (chronic). Treatment groups were acute bilateral (3 swine, 6 ablations with immediate computed tomography [CT] and sacrifice); chronic single kidney (3 swine, 3 ablations; CT at day 0, week 1, and week 4 after treatment, followed by sacrifice); and chronic bilateral (1 swine, 2 ablations). Treatments were performed using a prototype system (VortxRx; HistoSonics, Inc) and targeted a 2.5-cm-diameter sphere in the lower pole of each kidney, intentionally including the central collecting system. Results Mean treatment time was 26.4 minutes. Ablations had a mean diameter of 2.4 ± 0.3 cm, volume of 8.5 ± 2.4 cm3, and sphericity index of 1.00. Median ablation volume decreased by 96.1% over 4 weeks. Histology demonstrated complete lysis with residual blood products inside the ablation zone. Temporary collecting system obstruction by thrombus was observed in 4/11 kidneys (2 acute and 2 chronic) and resolved by 1 week. There were no urinary leaks, main vessel thromboses, or adjacent organ injuries on imaging or necropsy. Conclusions In this normal porcine model, renal RAST demonstrated complete histologic destruction of the target renal tissue while sparing the urothelium.

The risk of electromagnetic interference between microwave (MW) ablation and cardiac implantable electronic devices (CIEDs), ie, pacemakers and defibrillators, has not been fully evaluated. Fourteen MW ablations (kidney, n = 8; liver, n = 5; lung, n = 1) were performed in 13 patients with CIEDs in normal operating mode. Electrocardiography tracings, cardiovascular complications, tumor size, tumor-to-CIED distance, and tumor-to-device lead distance were recorded. Mean tumor size was 2.9 cm, mean tumor-to-CIED distance was 26.4 cm (range, 9–30 cm), and mean tumor-to-lead distance was 12.1 cm (range, 3.5–20 cm). No device-based cardiovascular complications or class C or higher complications per Society of Interventional Radiology criteria were identified. MW ablation appears to be safe in select patients with CIEDs.