Secondary Efficacy Rates Research Articles

Outcomes and Complications of Image-Guided Percutaneous Tumour Ablation for Hepatocellular Carcinoma at the Irish National Liver Transplant Centre.

Background: Image-guided tumour ablation is a minimally invasive treatment for early stage hepatocellular carcinoma (HCC). Our study reviews the complications and long term outcomes in patients treated at a tertiary referral centre. Methods: Retrospective study. All patients with HCC who underwent microwave ablation (MWA) or radiofrequency ablation (RFA) from 1st January 2014 to 31st December 2022 were identified. Treatment response of target lesion, complications, and survival were recorded. Results: One hundred seventy ablations were performed in 118 patients; 70% MWA, 30% RFA. Median radiological follow-up 21 months (range 3-107). Follow-up imaging was reported using LI-RADS and mRECIST. At first follow-up imaging, 94 patients had complete response (primary efficacy rate 80.3%) while 19.7% (n = 23) had residual disease. Fifteen of these had repeat ablation; 10 had complete response (secondary efficacy rate 85.6%). By end of study duration, 70.5% (n = 79) achieved sustained local complete response from single ablation without documented recurrence. 14.3% (n = 16) required more than one ablation of target lesion. Overall, 84.8% (n = 95) demonstrated long term local complete response to ablation. Complication occurred in 5.9% (n = 10); 40.0% Grade I, 40.0% Grade II, 10.0% Grade III, 10.0% Grade IV as per the CIRSE Classification. 1-, 3-, and 5-year overall survival (OS) rate was 97%, 68%, and 61% respectively. Mean OS was 5.3 years (median 4.7). No difference in OS (P = .7) or local progression free survival (P = .5) between patients treated with MWA versus RFA. Conclusion: This study demonstrates excellent long-term response to TA, with acceptable complication profile. No difference in survival between RFA versus MWA.

Microwave ablation of 105 T1 renal tumors: technique efficacy with a mean follow-up of two years.

Thermal ablation (TA) with radiofrequency (RFA) or cryoablation (CA) are established treatments for small renal masses (≤4 cm). Microwave ablation (MWA) has several potential benefits (decreased ablation time, less susceptibility to heat-sink, higher lesion temperatures than RFA) but is still considered experimental considering the available small-sample studies with short follow-up. To evaluate technique efficacy and complications of our initial experience of renal tumors treated using percutaneous MWA with a curative intent. A total of 105 renal tumors (in 93 patients) were treated between April 2014 and August 2017. MWA was performed percutaneously with computed tomography (CT) guidance under conscious sedation (n=82) or full anesthesia. Patients were followed with contrast-enhanced CT scans at six months and yearly thereafter for a minimum of five years. The mean follow-up time was 2.1 years. The percentage of tumors completely ablated in a single session (primary efficacy rate) and those successfully treated after repeat ablation (secondary efficacy rate) were recorded. Patient and tumor characteristics as well as complications were collected retrospectively. The median patient age was 70 years and median tumor size was 25 mm. Primary efficacy rate was 96.2% (101/105 tumors). After including two residual tumors for a second ablation session, secondary efficacy was 97.1% (102/105). Periprocedural complications were found in 5.2% (5/95) sessions: four Clavien-Dindo I and one Clavien-Dindo IIIa. One postprocedural Clavien-Dindo II complication was found. MWA has high efficacy rates and few complications compared to other TA methods at a mean follow-up of two years.

Microwave Ablation of Adrenal Tumors in Patients With Continuous Intra-Arterial Blood Pressure Monitoring Without Prior Alpha-Adrenergic Blockade: Safety and Efficacy.

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 3.3cm (1.4-6.9cm) 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 211mmHg (range: 132-288), with an average increase in SBP of 100mmHg (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 3.0min (range: 1-12). The technical success rate was 100% (15/15 procedures). The mean follow-up time was 2.4years (range: 0.9-7.7years), 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.

Percutaneous Microwave Ablation of Histologically Proven T1 Renal Cell Carcinoma

ObjectivesTo assess the safety and efficacy of percutaneous microwave ablation (MWA) of histologically proven T1 renal cell carcinoma (RCC).MethodsWe analysed patients with a histologically proven RCC (≤ 7 cm) treated by MWA from April 2012–April 2018. Primary and secondary efficacy, local tumour recurrence (LTR), morbidity and mortality were reported. Efficacy was defined as no residual tumour enhancement on follow-up imaging 1 month after the first ablation (primary efficacy) and after re-ablation(s) for residual disease (secondary efficacy). Adverse events (AE) were registered by the Clavien–Dindo classification and the common terminology criteria for AE. Univariable and multivariable logistic regression analyses were performed to investigate a relation among pre-treatment factors incomplete ablation and complications.ResultsIn 100 patients, a total of 108 RCCs (85 T1a and 23 T1b) were treated by MWA. Median size was 3.2 cm (IQR 2.4–4.0). Primary efficacy was 89% (95%CI 0.81–0.94) for T1a lesions and 52% (95%CI 0.31–0.73) for T1b lesions (p < 0.001). Fifteen lesions (7 T1a) were re-ablated for residual disease by MWA in one (n = 13) and two (n = 2, both T1b) sessions resulting in secondary efficacy rates of 99% (T1a) and 95% (T1b, p = 0.352). LTR occurred in four tumours (2 T1a, 2 T1b) after 10–60 months. Six (4%) AEs grade > 3–5 were observed (2 T1a, 4 T1b, p = 0.045). Multivariable analysis showed that mR.E.N.A.L. nephrometry was independently associated with incomplete ablation (p = 0.012).ConclusionMicrowave ablation is safe and effective for T1a and T1b RCC lesions with a significantly lower primary efficacy for T1b lesions.

Percutaneous Laser Ablation of Liver Metastases from Neuroendocrine Neoplasm. A Retrospective Study for Safety and Effectiveness.

To retrospectively assess safety and efficacy of laser ablation (LA) of multiple liver metastases (LM) from neuroendocrine neoplasms (NEN). Twenty-one patients with NEN and at least 3 LM ≤ 4cm in diameter underwent ultrasonography-guided LA. Up to seven LM were ablated in a single session; if the number of LM exceeded seven, the remaining LM were ablated in further LA sessions with a time interval of 3-4 weeks. LA was performed according to the multifiber technique. The patients underwent contrast-enhanced CT 1 month after LA, and were subsequently monitored every 3 months for the first 2 years and then every 6 months. In total, 189 LM were treated in 21 patients (mean 9 ± 8.2, median 6) in 41 LA sessions (range 1-5). The diameter of LM ranged from 5 to 35mm (median 19mm, mean 17.9 ± 6.4mm). One grade 4 complication occurred (0.53%): a bowel perforation managed by surgery. Technical efficacy was 100%, primary efficacy rate 94.7%, and secondary efficacy rate 100%. Complete relief of hormone-related symptoms was obtained in all the 13 symptomatic patients. Median follow-up was 39months (range 12-99). 1-, 2-, 3-, and 5-year survival rates were 95%, 86%, 66%, and 40%, respectively. Overall survival resulted higher for patients with Ki-67 expression ≤ 7% than for those with Ki-67 > 7% (p = 0.0347). LA is a promising and safe technique to treat LM from NEN. A longer follow-up should provide definitive information on the long-term efficacy of this liver-directed therapy. Retrospective study, local non-random sample, level 3.

04:12 PM Abstract No. 187 Efficacy and outcomes following percutaneous microwave ablation of hepatocellular carcinomas (HCC) measuring between 3 and 5 cm

Tumors greater than 3 cm have been considered less favorable for local percutaneous treatment, due to association with vascular invasion and higher histologic grade. The purpose of this study was to evaluate technical success and clinical outcomes of patients with HCC between 3-5 cm treated with CT-guided percutaneous microwave ablation (MWA). An institutional database was used to identify adult patients with HCC between 3-5 cm that were treated with CT-guided percutaneous MWA between August 2008 and December 2017. Patient demographics, tumor characteristics, and patient performance status were recorded. The diagnosis of HCC was established by biopsy or imaging criteria (OPTN). Primary efficacy rate was defined as the percentage of treated tumors that showed complete ablation of macroscopic tumor on the first follow-up scan. Secondary efficacy rate was defined as the percentage of residual tumors identified on post-procedure imaging (< 60 days) that were successfully re-treated. Once primary or secondary efficacy was achieved, patients were re-imaged at approximately 3-month intervals until they were censored due to loss of follow-up, death or transplantation. 367 patients underwent 544 MWA procedures over the study period. 61 patients (50 male, 11 female), had a diagnosis of HCC and lesion size of between 3 and 5 cm. Hydrodissection was performed in 27 cases. Mean follow-up was 822 days (range 27-3191). Of 61 lesions treated, no recurrence developed in the treated lesion in 41 cases. In the remaining 20 cases, recurrence developed, with mean time to recurrence of 335 days (range 24 – 1000 days). Recurrent tumor was managed with repeat ablation and/or intra-arterial therapy. Early recurrence (< 60 days) occurred in 3 cases, and was successfully treated with repeat ablation in two patients. 15 patients went on to subsequent liver transplantation, with analysis of the explants revealing no viable residual tumor in that area in 8 cases. There were 7 minor and no major complications. Advances in thermal ablation technology now allow for treatment of larger HCCs, with this study showing primary and secondary efficacy rates of 95.1% and 98.3%, respectively.

Periprocedural outcome after laparoscopic partial nephrectomy versus radiofrequency ablation for T1 renal tumors: a modified R.E.N.A.L nephrometry score adjusted comparison.

Comparable oncological outcomes have been seen after surgical nephrectomy and thermal ablation of renal tumors recently. However, periprocedural outcome needs to be assessed for aiding treatment decision. To compare efficacy rates and periprocedural outcome (technical success, session time, hospitalization time, and complications) after renal tumor treatment with laparoscopic partial nephrectomy (LPN) or radiofrequency ablation (RFA). The initial experience with 49 (treated with LPN) and 84 (treated with RFA) consecutive patients for a single renal tumor (diameter ≤ 5 cm, limited to the kidney) during 2007-2014 was evaluated. Patient and tumor characteristics, efficacy rates, and periprocedural outcome were collected retrospectively. The stratified Mantel Haenzel and Van Elteren tests, adjusted for tumor complexity (with the modified R.E.N.A.L nephrometry score [m-RNS]), were used to assess differences in treatment outcomes. Primary efficacy rate was 98% for LPN and 85.7% for RFA; secondary efficacy rate was 93.9% for LPN and 95.2% for RFA; and technical success rate was 87.8% for LPN and 100% for RFA. Median session (m-RNS adjusted P < 0.001; LPN 215 min, RFA 137 min) and median hospitalization time were longer after LPN (m-RNS adjusted P < 0.001; LPN 5 days, RFA 2 days). Side effects were uncommon (LPN 2%, RFA 4.8%). Complications were more frequent after LPN (m-RNS adjusted P < 0.001; LPN 42.9%, RFA 10.7%). Both methods achieved equivalent secondary efficacy rates. RFA included several treatment sessions, but session and hospitalization times were shorter, and complications were less frequent than for LPN. The differences remained after adjustment for renal tumor complexity.

Ultrasound-guided percutaneous laser ablation is safe and effective in the treatment of small renal tumors in patients at increased bleeding risk

Purpose: The aim of this retrospective study was to assess the safety and effectiveness of laser ablation (LA) in patients with small renal cell carcinomas (RCC) and increased risk of bleeding.Material and methods: From 2013 to 2017, nine patients (six males, three females, aged 68.5 ± 12.2 years) at high risk of bleeding underwent ultrasonography-guided LA for an RCC. Patients were considered at increased risk of bleeding because of impairment of coagulation parameters, concomitant antiplatelet therapy, or at-risk location of the tumor (one, five, and three patients, respectively). RCC diameter ranged from 11 to 23 mm. According to tumor size, two or three laser fibers were introduced through 21-gauge needles and 1800 J per fiber were delivered in 6 min with a fixed power of 5 W. Major and minor complications, technical success, and primary and secondary technical effectiveness and tumor recurrence were recorded.Results: Just one Grade 1 complication was observed: a small asymptomatic hematoma that spontaneously resolved. Technical success was 100%, 1 month technical efficacy was 88.9% (8/9 patients). One patient with residual tumor was successfully retreated 1 month later, and secondary efficacy rate was 100%. No local tumor recurrence occurred during a median follow-up of 26 months (range 11–49 months).Conclusions: LA is safe and effective in the treatment of small RCC and might represent a valid option in patients with increased risk of bleeding.

Radiofrequency ablation of pulmonary metastases from sarcoma: single-center retrospective evaluation of 46 patients

This retrospective, single-center study evaluated radiofrequency (RF) ablation for pulmonary metastases of sarcoma. Forty-six patients with sarcoma (144 pulmonary metastases) underwent 88 RF ablation sessions. Data regarding local tumor progression, efficacy, procedural adverse events (AEs; National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0), overall survival (OS), and OS-associated prognostic factors were retrospectively evaluated using univariate analyses. Local progression occurred in 22 of 144 tumors (15.3%). Primary and secondary efficacy rates were 83.5 and 90.0% at 1year and 76.3 and 81.4% at 2years, respectively. Seventy-three grade 1 AEs, 33 grade 2 AEs, and no grade≥3 AEs were observed. Twenty-eight patients (60.9%) remained alive and 18 died, yielding 1-, 2-, and 3-year OS rates of 80.6, 70.1, and 47.1% (median survival time, 31.7months). Univariate analysis revealed extrapulmonary metastasis (P=0.005), noncurative RF ablation (P=0.009), and a post-RF ablation disease-free interval of ≤12months (P=0.015) as significant negative prognostic factors. RF ablation is safe, offers good local control, and may be a viable treatment option for pulmonary metastasis of sarcoma.

Novel Infectious Agent-Free Hemostatic Material (TDM-621) in Cardiovascular Surgery

Currently, hemostatic materials made from human blood components and animal-derived collagen is used for controlling operative hemorrhage in the cardiovascular surgery field. In this study, we focused on an entirely synthetic self-assembling peptide (development code: TDM-621) that gels when in contact with blood or other bodily fluids and stops bleeding upon contact with a wound site. We investigated its usefulness as a hemostatic material in animal and clinical studies. Before we began the clinical study, we demonstrated the hemostasis efficacy and safety of TDM-621 in animal experimental models. Twenty-five patients (22 men, 3 women) were enrolled in the clinical study, and the following procedures were performed: 1) coronary artery bypass graft (CABG) (n = 9), 2) abdominal aortic graft replacement (n = 4), and 3) peripheral artery bypass (n = 12). The TDM-621 material was applied to a total of 33 vascular anastomotic graft sites (some patients received material at more than one site). Both hemostatic efficacy and safety were examined. A total of 33 anastomotic graft sites in 25 patients were evaluated, and the averaged primary and secondary efficacy rate was 94.5%. No postoperative bleeding or adverse events (including serious adverse events) with a causal relationship to treatment were observed. This study indicated that TDM-621 is a more effective and reliable hemostat than commonly-used general hemostatic agents and, therefore, will be very useful in several cardiovascular surgery applications.