Primary Effectiveness Rate Research Articles

Comparative analysis of long term effectiveness of Neuroform Atlas stent versus low profile visualized intraluminal stent/Woven EndoBridge devices in treatment of wide necked intracranial aneurysms

BackgroundWe compared the outcomes of wide necked aneurysms (WNA) treated with the Neuroform Atlas with those treated with the low profile visualized intraluminal stent (LVIS) or the Woven EndoBridge (WEB).MethodsObjective,...

Treatment of large and giant posterior communicating artery aneurysms with the Surpass streamline flow diverter: results from the SCENT trial

BackgroundThe Surpass flow diverter was developed to treat intracranial aneurysms not amenable to standard treatment. Indications for use allow placement in the internal carotid artery to the terminus, including the...

Radiofrequency ablation (RFA) of T1a renal cancer with externally cooled multitined expandable electrodes.

To retrospectively evaluate the mid-term outcomes of percutaneous radiofrequency ablation (RFA) with multitined expandable electrodes externally cooled with saline solution in patients with T1a renal cell carcinoma (RCC). In this retrospective study, we evaluated 39 RCC in 35 patients treated with CT-guided RFA in 41 procedures (2011-2017). All patients were staged T1a, N0, M0 prior to RFA. Mean tumor size was 24.48mm. A 4-tined expandable RFA electrode cooled with pump-circulating saline was used. Efficacy was evaluated verifying complete tumor necrosis (no contrast enhancement on imaging) at the end of the procedure and on subsequent controls. Follow-up observation period was 5years. Minor/major complications, hospitalization days, serum creatinine and GFR pre- and post-RFA (compared using paired t test) and post-operative pain (evaluated with NRS after treatment) were considered as safety indicators. Overall survival was also calculated (Kaplan-Meier method). Of 35 patients, 30/35 had 1 treatment (primary effectiveness rate 86%), 4/35 had 2 treatments and 1/35 had 3 treatments for residual disease. There were no relapses and no mid-long-term complications; 3 minor (8%) and 1 major (2.7%) complications during perioperative period were reported. Mean before and after RFA serum creatinine rates were, respectively, 1.08mg/dl and 1.11mg/dl (p value: 0.4117). NRS median value is 0.8. Hospitalization days median value is [2.8 ± 1.9] days. 91.4% of all patients survived, with a median overall survival time of 65months. Mid-term results show that CT-guided RFA with multitined expandable electrodes externally cooled with saline solution is an effective and safe treatment in patients with RCC-staged T1aN0M0. Data reported in our study are in line with data reported in the literature from patients treated with other devices.

Abstract WMP36: Surpass™ IntraCranial Aneurysm EmbolizatioN System Pivotal Trial to Treat Large OR Giant Wide Neck Aneurysms (SCENT Trial): One Year Outcomes

Introduction: Surpass™ Flow Diverter was developed to treat large or giant wide-neck intracranial aneurysms (IA) not amenable to surgical or current standard endovascular treatment due to location, morphology, or known treatment challenges. FDA approved on July 13 2018, Surpass™ fulfills an unmet clinical need. Indications for Use allow for placement in the entire intracranial internal carotid artery (ICA). Surpass™ is available in diameters of 3 to 5 mm and lengths of 15 to 50 mm. Methods: SCENT Trial is an international, multi-center, prospective, non-randomized trial comparing the outcomes of Surpass™ Flow Diverter treatment to historical control. It is designed to evaluate the safety and efficacy of Surpass™ for treatment of wide-neck (≥4mm), large or giant IA ≥10 mm in size. The primary safety endpoint is the percent of subjects experiencing neurologic death or major ipsilateral stroke at 12 months. The primary effectiveness endpoint is the percent of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis (≤50% stenosis) of the parent artery, and any retreatment of the target aneurysm at 12-month. Results: From 2012 to 2015, 180 subjects were treated at 26 sites. Mean age was 61.0 years and 91.7% (165/180) were females. Aneurysms were most frequently located in the carotid-ophthalmic segment (33.3%; 60/180), followed by the cavernous segment (28.9%; 52/180), posterior communicating artery (21.1%; 38/180), supraclinoid carotid artery (11.1%; 20/180), superior hypophyseal artery (3.3%; 6/180), and the petrous segment (2.2%; 4/180). Mean aneurysm dimension included dome height 13.4±5.7 mm. Mean neck width was 6.7 mm. Technical success occurred in 97.8% (176/180) of subjects while the mean number of Surpass™ devices used was 1.1 per procedure, with 86.7% (156/180) of aneurysms treated with a single flow diverter. The 12-month primary effectiveness rate was 62.8% [(113/180), 95% CI 55.3, 69.9] and 12-month major ipsilateral stroke or neurological death rate of 10.6% [(19/180), 95% CI 55.3, 69.9] Conclusions: Surpass™ Flow Diverter is safe and effective to treat large and giant aneurysms intracranial internal carotid aneurysms.

Clinical outcomes of laparoscopic radiofrequency ablation of single primary or recurrent hepatocellular carcinoma (≤3 cm).

PurposePercutaneous radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC) has some limitations such as poor sonic window and injury to adjacent organs. The laparoscopic approach has been suggested as an alternative option. The aim of this study was to show the safety and efficacy of laparoscopic RFA for single, small (≤3 cm), and primary or recurrent HCC that is not suitable for percutaneous RFA or surgical resection.MethodsWe reviewed the cases of 37 patients (32 men and 5 women, mean age 61 ± 8.1 years) who underwent laparoscopic RFA for single, small HCC (≤3 cm) that was unsuitable for percutaneous RFA or surgical resection.ResultsThe technical success rate was 94.6% and 34 patients (95%) had no complications. There were no conversions to open RFA and no operative mortality. The primary effectiveness rate 1 month after the procedure was 100%. The overall recurrence rates at 3, 6, 12, and 24 months after the laparoscopic RFA were 8.1%, 14.4%, 25%, and 35.7%, respectively. The local tumor progression rate was 4.2% at 6 months and 8.7% at 9 months.ConclusionLaparoscopic RFA is a safe and effective treatment for HCC cases that are unsuitable for percutaneous RFA.

Ultrasonic guided percutaneous ethanol injection with or without combined radiofrequency ablation for hepatocellular carcinomas

The aim of this retrospective study was to evaluate whether radiofrequency ablation (RFA) combined percutaneous ethanol injection (PEI) in the management of hepatocellular carcinoma (HCC) improves treatment outcomes. We retrospectively included 66 HCC patients who received RFA or RFA plus PEI from February 2011 to January 2014 in Jingmen No. 1 People's Hospital. Moreover, 31 cases received RFA plus PEI as the experiment group and 35 subjects treated with RFA aloe as the control group. The overall survival and treatment related complications were compared between the two groups. For RFA group, the 1-year, 2-year, and 3-year survival rate were 82.0%, 69.3%, and 30.7%, respectively, with the median survival time of 27.1 months. For RFA plus PEI group, the 1-year, 2-year, and 3-year survival rate were 97.1%, 73.9%, and 37.5%, respectively, with the median survival time of 33.6 months. The overall survival of the two groups was not statistical different with the hazard ratio of 1.48 (P > 0.05); three cases of treatment associated complications were found in RFA group with 1 abscess, 1 pleural effusion, and 1 portal vein thrombosis. Moreover, 2 cases of complication were recorded in RFA plus PEI group with 1 pleural effusion and 1 portal vein thrombosis. The complicated incidence rate was not statistical different between the two groups (P < 0.05). The combination treatment of HCC was safe and had a slightly higher primary effectiveness rate than RFA alone.

Radiofrequency ablation guided by contrast-enhanced ultrasound for hepatic malignancies: Preliminary results

To evaluate whether contrast-enhanced ultrasound (CEUS)-guided radiofrequency ablation (RFA) can be performed effectively in small hepatic malignancies that are invisible or poorly visualized at traditional grey-scale ultrasonography (US). The institutional ethics committee approved the study, and all patients provided written informed consent before their enrolment. The study focused on 55 patients (43 men, 12 women, age 57.4 ± 10.9 years) with 60 hepatic lesions from May 2010 to March 2011. All lesions were treated with multipolar radiofrequency ablation (RFA). During the RFA procedure, with the injection of ultrasound contrast agent (sulphur hexafluoride; SonoVue, Bracco Imaging Spa, Milan, Italy), RFA was conducted under CEUS guidance when the optimal depiction of a lesion was obtained. Artificial pleural effusions were used in those cases obstructed by the lungs. Twenty-four hours after RFA, contrast-enhanced MRI was used as the reference standard to evaluate the primary effectiveness rate and complete tumour necrosis. The follow-up time was 12-24 months (median 15 months). Among 60 hepatic malignancies, CEUS detected 57 lesions (95%), which was higher than that at US (26.6%). Artificial pleural effusions were performed in three cases, resulting in the detection of three additional lesions. The insertion of RFA electrodes was monitored by CEUS in all lesions. Immediately after RFA, complete tumour necrosis were achieved in all 60 lesions as apparent at MRI, for a primary effectiveness rate of 100%. CEUS-guided RFA is a promising technique for targeting and improving the efficiency of treatment of hepatic malignancies.

Local Tumor Progression of Hepatocellular Carcinoma After Microwave Percutaneous Ablation: A Preliminary Report.

BackgroundMicrowaves (MW) technology is an ablative treatment alternative to radiofrequency (RF) for early stages of hepatocellular carcinoma (HCC) in cirrhotic patients not suitable for surgical resection. It is well known that HCC lesions ≥ 30 mm treated by RF show a high rate of local tumor progression because of residual of unablated neoplastic tissue.MethodsAim of this study was to describe a limited experience of MW ablation (9 cirrhotic patients with medium size HCC: 11 lesions, 31 - 50 mm in diameter) treated from June 2009 to May 2010 by one of currently marketed western MW ablation systems and followed up for 2 years. Primary end-point was the probability of local tumor progression at 24 months; secondary end-point was the safety of the procedure.ResultsRadiological response after a single session and re-evaluation of local tumor progression along the time were performed by contrast enhanced computed-tomography at months 1-8-12-24. Early effectiveness rate was 90.1 %. The cumulative incidence of local tumor progression at 1 and 2 years were 36.4% (95% CI 11.2 - 62.7) and 57.6% (95% CI 23.6 - 81.0). We observed a single minor complication of the procedure.ConclusionsIn conclusion, MW ablation system “Amica” has a high rate of primary effectiveness rate but residual of unablated neoplastic tissue induce local tumor progression in about half of the cases during the following 2 years.

Single-session Percutaneous Ethanol Ablation of Early-stage Hepatocellular Carcinoma with a Multipronged Injection Needle: Results of a Pilot Clinical Study

To investigate the feasibility, safety, and efficacy of single-session ethanol ablation with multipronged needles in the treatment of early-stage hepatocellular carcinoma (HCC). A pilot clinical study enrolled 20 patients with Child-Pugh A-B cirrhosis (15 men and 5 women 53-84 years old [mean 70.3 years old ± 8.3, median 72 years old]) and with 25 HCC tumors 1.2-3.8 cm in longest diameter (mean 2.3 cm ± 0.6) located in unfavorable locations for radiofrequency (RF) ablation. Ethanol ablation was performed under moderate sedation using a multipronged injection needle (Quadra-Fuse; REX Medical, Conshohocken, Pennsylvania) and ultrasound guidance. Follow-up period ranged from 12-24 months (mean 15.9 months ± 4.6, median 16 months) and included contrast-enhanced computed tomography (CT) or magnetic resonance (MR) imaging performed 1 month after treatment and at 3-month intervals thereafter. The treatment protocol was successfully completed in all patients (technical success rate 100%). No major complications were observed. A single treatment session with injection of 5-26 mL of ethanol (mean 9.5 mL ± 5.5) resulted in complete tumor ablation at 1 month CT or MR imaging in 21 (84%) of 25 tumors. A second treatment session increased the number of tumors with complete response (CR) to 23 of 25 (primary effectiveness rate 92%). Tumor progression was observed in three cases during the follow-up period, for a rate of confirmed CR of 80% (20 of 25). Ethanol ablation performed with a multipronged injection needle was not associated with any major complications and resulted in a high rate of confirmed CR. This technique offers an alternative to RF ablation for single-session treatment of early-stage HCC.

Comparison of Percutaneous and Surgical Approaches to Renal Tumor Ablation: Metaanalysis of Effectiveness and Complication Rates

To determine the effectiveness and complication rates of ablation of renal cell carcinoma (RCC) performed with a percutaneous approach versus a surgical approach. A search performed on PubMed identified series of renal tumor ablations. Keywords searched included "radiofrequency" (RF), "cryoablation", "cryosurgery", "cryotherapy", "ablation", "renal", "kidney", and "RCC". Review articles were excluded from the search of English-language literature from January 1996 through August 2006. Inclusion criteria were (i) more than one case, (ii) use of RF ablation or cryoablation, (iii) effectiveness based on follow-up imaging, and (iv) report of complication rate. Effectiveness was defined by the proportion of tumors without residual enhancement after one treatment session (ie, primary effectiveness) or after repeated treatments (ie, secondary effectiveness). Major complications were defined as events with substantial morbidity, disability, or increasing level of care. Metaanalysis was performed on primary effectiveness, secondary effectiveness, and major complication rates with a random-effects model. Differences were considered significant if the 95% CIs did not overlap. Forty-six series (28 percutaneous, 18 surgical) met all inclusion criteria. The primary effectiveness rate for the percutaneous group (87%) was significantly lower than that in the surgical group (94%; P < .05). The secondary effectiveness rate in the percutaneous treatment group (92%) was not significantly different from that in the surgical treatment group (95%; P > .05). The major complication rate in the percutaneous treatment group (3%) was significantly lower than that in the surgical treatment group (7%; P < .05). Based on a metaanalysis, when ablating renal tumors, a percutaneous approach was safer than an open or laparoscopic approach and was equally effective. However, more than one procedure was needed to treat the tumor completely.

Combined Percutaneous Radiofrequency Ablation and Ethanol Injection for Hepatocellular Carcinoma in High-Risk Locations

The purpose of this study was to investigate whether combining percutaneous ethanol injection (PEI) with radiofrequency ablation in the management of hepatocellular carcinoma (HCC) in high-risk locations improves treatment outcomes. We compared the outcome of management of high-risk tumors with PEI and radiofrequency ablation (n = 50) or radiofrequency ablation alone (n = 114) with the outcome of radiofrequency ablation of non-high-risk tumors (n = 44). We also compared the survival rates of patients with and those without high-risk HCC. PEI was performed into the part of the tumor closest to a blood vessel or vital structure before radiofrequency ablation. The study included 142 patients with 208 HCCs managed with radiofrequency ablation. Despite larger tumor sizes (2.8 +/- 1 cm vs 1.9 +/- 0.7 cm vs 2.5 +/- 0.1 cm for the high-risk radiofrequency plus PEI, non-high-risk radiofrequency, and high-risk radiofrequency groups, respectively; p < 0.001), the primary effectiveness rate of high-risk radiofrequency ablation and PEI (92%) was similar to that of non-high-risk radiofrequency ablation (96%). The primary effectiveness rate of high-risk radiofrequency ablation and PEI was slightly higher (p = 0.1) than that of high-risk radiofrequency ablation (85%). The local tumor progression rates (21% vs 33% vs 24% at 18 months) of the three respective groups were not statistically different (p = 0.91). Patients with and those without high-risk tumors had equal survival rates (p = 0.42) after 12 (87% vs 100%) and 24 (77% vs 80%) months of follow-up. Independent predictors of primary effectiveness were a tumor size of 3 cm or less (p = 0.01) and distinct tumor borders (p = 0.009). Indistinct borders (p = 0.033) and non-treatment-naive status of HCC (p = 0.002) were associated with higher local tumor progression rates. The only predictor of survival was complete ablation of all index tumors (p = 0.001). The combination of radiofrequency ablation and PEI in the management of HCC in high-risk locations has a slightly higher primary effectiveness rate than does radiofrequency ablation alone. A randomized controlled study is warranted.

Complications of Laser Ablation for Hepatocellular Carcinoma: A Multicenter Study

To retrospectively and prospectively determine the rate and type of complications and their association with clinical or technical factors after percutaneous laser ablation (LA) for hepatocellular carcinoma (HCC). The institutional research board of each center approved the study and all patients provided informed consent. By using an Internet liver tumor database of nine Italian centers, 520 patients were included with HCC nodules of any size (small, 0-3 cm; intermediate, >3-5 cm; large, >5 cm). Postprocedural complications were related to clinical or percutaneous LA factors by using the Student t and chi(2) tests. Follow-up was carried out with computed tomography (CT) at 1, 3, 6, 9, and 12 months, and primary effectiveness rate was defined as the percentage of HCCs completely ablated after percutaneous LA. A total of 353 men and 147 women (age range, 24-86 years; Child-Pugh score A = 63.4%, B = 30.8%, C = 5.9%) with 647 nodules (mean diameter, 3.2 cm +/- 1.7) were treated by 1004 percutaneous LA sessions. There were four (0.8%) deaths in 520 patients; 15 (1.5%) of 1004 sessions presented major complications without any seeding. Major complications were associated with excess energy (10 520 J +/- 7073 vs 7474 J +/- 3803; P = .001) and high-risk location (P = .05). Sixty-two (6.2%) sessions resulted in minor complications associated with excess energy (P = .001), high bilirubin level (1.74 mg/dL +/- 1.10), and low prothrombin time (P = .01). Primary effectiveness rates were 60% in all HCCs and 81% in HCCs smaller than 3 cm. Percutaneous LA may be considered a safe treatment for small HCCs.

Combined Hepatectomy and Radiofrequency Ablation for Multifocal Hepatocellular Carcinomas: Long-term Follow-up Results and Prognostic Factors

For multifocal hepatocellular carcinomas (HCCs) that are untreatable with resection only, locoregional therapies added to hepatectomy have been introduced. However, some preliminary reports have documented average survival results and relatively high complication rates. We evaluated the long-term survival results and safety of combined hepatectomy and radiofrequency ablation (RFA) in patients with HCCs and assessed the prognostic factors affecting their survival. A total of 53 patients who had 148 HCCs in their livers underwent hepatectomy combined with ultrasound-guided intraoperative RFA. The mean diameter of the 82 resected tumors was 4.8 cm (range 1.3-21.0 cm) and that of 66 ablated tumors was 1.5 cm (range 0.8-3.5 cm). We evaluated the primary effectiveness rates, survival rates, and complications. In addition, we assessed the prognostic factors associated with the survival rates using Cox proportional hazard models. The primary effectiveness rate of RFA was 98% (65 of 66). Local tumor progression was observed in two (3%) ablation zones of 65 tumors with complete primary effectiveness. The cumulative survival rates at 1, 2, 3, 4, and 5 years were 87, 83, 80, 68, and 55%, respectively. Patients with smaller resected tumors (< or = 5 cm) demonstrated better survival results (P = 0.004). No procedure-related deaths occurred. We observed hepatectomy-related complications in 4 patients (8%, 4 of 53) and an RFA-related complication in 1 patient (2%, 1 of 53). Combined hepatectomy and RFA is an effective and safe treatment modality for multifocal HCCs. Resected tumor size was a significant prognostic predictor of long-term survival.

Percutaneous Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Hepatectomy: Long-term Results and Prognostic Factors

We evaluated the long-term survival results and safety of percutaneous radiofrequency ablation (RFA) for recurrent hepatocellular carcinoma (HCC) after hepatectomy, and assessed the prognostic factors that can influence its long-term therapeutic results. One hundred and two patients, who had 119 recurrent HCC in their livers, underwent ultrasound-guided percutaneous RFA. All the patients had a history of hepatic resection as a first-line treatment modality for HCC. The mean diameter of the recurrent tumors was 2.0 cm (range, 0.8-5.0 cm). We evaluated the effectiveness rates, local tumor progression rates, survival rates, and complications. We also assessed the prognostic factors of the survival rates by using Cox proportional hazard models. The primary effectiveness rate was 93.3% (111 of 119). The cumulative rates of local tumor progression at 1, 3, and 5 years were 6.0, 8.6, and 11.9%, respectively. The cumulative survival rates at 1, 2, 3, 4, and 5 years were 93.9, 83.7, 65.7, 56.6, and 51.6%, respectively. Patients with a lower serum alpha-fetoprotein (AFP) level (<or=100 microg/L) before RFA or with small resected tumors (<or=5 cm) demonstrated better survival results (P < .05). There was only one major complication (liver abscess, 1.0% per treatment) during the follow-up period. There were no procedure-related deaths. Percutaneous RFA is an effective and safe treatment modality for intrahepatic recurrent HCC after hepatectomy. Serum AFP level before RFA and resected tumor size were significant prognostic predictors of long-term survival.

Laserinduzierte Thermotherapie (LITT) von Lebertumoren in zentraler Lokalisation: Ergebnisse und Komplikationen

To investigate whether laser-induced thermotherapy (LITT) for tumors of the liver in central location is a sufficient and safe therapeutic option. According to predefined criteria, 23 of 136 patients were chosen to be treated with LITT because of malignant liver tumors. At the time of the first LITT, the patients had 28 central tumors (27 metastases, one HCC), which were treated in 34 sessions with 64 laser applications and had a clinical and imaging follow-up every 3 months. The primary effectiveness rate was 74.1% and the secondary effectiveness rate 82.1%. The mortality rate was 0%. Major complications occurred in one patient (hemorrhagic pleural effusion), while minor complications occurred in 10 patients. During the median follow-up of 20 months (range 3-57 months), local tumor progression developed in 22% of the tumors. The effectiveness rate was 78.6%, 71.4% and 64.3% after 3, 6 and 9 months. The median survival was 46.0 months (95% confidence interval: 28.6-47.1 months). In our patients, complications and ablation rate of laser-induced thermotherapy for central liver tumors do not differ from those in peripheral location as described in the literature.