scholarly journals Safety and effectiveness of a novel generator algorithm for bipolar vessel sealing: a randomised controlled chronic animal study

BMC Surgery ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Bernhard Kraemer ◽  
Christos Tsaousidis ◽  
Stephan Kruck ◽  
Martin Schenk ◽  
Marcus Scharpf ◽  
...  

Abstract Background Electrosurgical vessel sealers are gradually replacing conventional techniques such as ligation and clipping. Algorithms that control electrosurgical units (ESU), known as modes, are important for applications in different surgical disciplines. This chronic porcine animal study aimed to evaluate the safety and effectiveness of the novel thermoSEAL electrosurgical vessel sealing mode (TSM). The BiClamp® mode (BCM) of the renowned VIO® 300 D ESU served as control. BCM has been widely available since 2002 and has since been successfully used in many surgical disciplines. The TSM, for the novel VIO® 3 ESU, was developed to reduce sealing time and/or thermal lateral spread adjacent to the seal while maintaining clinical success rates. The primary aim of this study was to investigate the long-term and intraoperative seal quality of TSM. Methods The BiCision® device was used for vessel sealing with TSM and BCM in ten German Landrace pigs which underwent splenectomy and unilateral nephrectomy during the first intervention of the study. The seals were cut with the BiCision® knife. Ninety-nine arteries, veins and vascular bundles were chronically sealed for 5 or 21 days. Thereafter, during the second and terminal intervention of the study, 97 additional arteries and veins were sealed. The carotid arteries were used for histological evaluation of thermal spread. Results After each survival period, no long-term complications occurred with either mode. The intraoperative seal failure rates, i.e. vessel leaking or residual blood flow after the first sealing activation, were 2% with TSM versus 6% with BCM (p = 0.28). The sealing time was significantly shorter with TSM (3.5 ± 0.69 s vs. 7.3 ± 1.3 s, p < 0.0001). The thermal spread and burst pressure of arteries sealed with both modes were similar (p = 0.18 and p = 0.61) and corresponded to the histological evaluation. The measured tissue sticking parameter was rare with both modes (p = 0.33). Tissue charring did not occur. Regarding the cut quality, 97% of the seals were severed in the first and 3% in the second attempt (both with TSM and BCM). Conclusions The novel TSM seals blood vessels twice as fast as the BCM while maintaining excellent tissue effect and clinical success rates. Trial registration Not applicable.

2019 ◽  
Vol 53 (4) ◽  
pp. 284-291
Author(s):  
Hirokazu Onishi ◽  
Toru Naganuma ◽  
Koji Hozawa ◽  
Tomohiko Sato ◽  
Hisaaki Ishiguro ◽  
...  

Introduction: The purpose of the current study was to investigate the periprocedural and long-term outcomes of stent implantation for de novo subclavian artery (SCA) disease. Material and Methods: We retrospectively investigated consecutive patients with de novo SCA lesions undergoing elective endovascular therapy procedures at our center between April 2004 and September 2015. All patients were included in the analyses of periprocedural outcomes, including procedural and clinical success. Subsequently, patients who completed the clinical follow-up and were assessed with brachial systolic pressure differences between the diseased and the contralateral arms, or angiographic stenosis, after stent implantation with procedural success were included in the analyses of long-term outcomes, including primary patency. Results: There were 62 patients (median 71.0 years, interquartile range 65.3-76.0 years; 45 men) with 62 de novo SCA lesions included in the analyses of periprocedural outcomes. There were 46 stenoses (74.2%) and 16 occlusions (25.8%). Our results indicated high procedural success rates for overall (95.2%), stenotic (97.8%), and occlusive (87.5%) lesions. Similarly, high clinical success rates were observed for overall (91.9%), stenotic (93.5%), and occlusive (87.5%) lesions. The median follow-up time was 6.0 years (interquartile range, 2.6-8.3 years). There were 48 patients with 48 de novo SCA lesions included in the analyses of long-term outcomes. Primary patency estimates were 97.7% (1 year), 97.7% (3 years), 93.1% (5 years), and 87.6% (7 years). Also, we observed a high estimate for freedom from reintervention for the target vessel (93.8%). Conclusion: Stent implantation for de novo SCA disease can be performed successfully and safely with favorable periprocedural and long-term outcomes.


2017 ◽  
Vol 45 (2) ◽  
pp. 706-713 ◽  
Author(s):  
Chengen Wang ◽  
Min Yang ◽  
Xiaoqiang Tong ◽  
Jian Wang ◽  
Haitao Guan ◽  
...  

Objective To evaluate the long-term efficacy and safety of selective arterial embolization (SAE) in the treatment of renal angiomyolipomas (AMLs). Methods This was a retrospective review of medical records and imaging findings from patients with renal AMLs who attended our clinic and received SAE between January 2007 and January 2014. Only patents with complete medical records, preoperative computed tomography scans using typical imaging and follow-up data were included. Results A total of 79 patients were enrolled in the study. Technical and clinical success rates were 100% and 91% ( n = 72), respectively. Only two patients experienced major complications. Post-embolization syndrome (i.e. fever, abdominal pain, nausea or vomiting) was reported in 68 (86%) patients, but all symptoms were mild and resolved with conservative measures. Mean radiological and clinical follow-up periods were 16.8 and 35.9 months, respectively. In 75 (95%) patients, tumours decreased in size; mean ± SD tumour size significantly decreased from 8.4 ± 3.5 cm pre-embolization to 6.7 ± 3.0 cm post-embolization . Conclusions This study provides long-term evidence that SAE is a safe and effective method in the treatment of patients with renal AMLs.


2016 ◽  
Vol 7 (4) ◽  
pp. 195-198 ◽  
Author(s):  
Varun Yarramaneni ◽  
Dhanasekar Balakrishnan ◽  
IN Aparna ◽  
Akanksha Sachdeva ◽  
Nayana Prabhu

ABSTRACT Dental implants are the modern marvel and are widely accepted as a reconstructive treatment modality for tooth replacement. In recent times, there has been a marked progress in the clinical success rates of dental implants, but implant failures as a result of infections are continuing at an alarming rate of 8% per year, translating into 1 million failures worldwide. Perimucositis and peri-implantitis are the chief complications reported postimplant surgery that effects its short- and long-term success. Peri-implantitis is characterized by clinical and radiological bone loss around the implant accompanied with an inflammatory reaction of the peri-implant mucosa and is an irreversible condition, whereas perimucositis is a reversible inflammatory change. Implant surfaces provide an ideal substrate for bacterial adhesion forming a biofilm. Biofilm performs vast functions ranging from physical defensive barrier against phagocytic predation to working as a selective permeable barrier. This limits the diffusion of systemic antimicrobial agents that are capable of damaging the bacterial complexes. These rapidly growing bacteria give rise to a chronic infection which is difficult to eradicate by conventional antibiotic therapy. To inhibit peri-implant infections, various functional modifications in the implant surfaces have been suggested. The coatings on the titanium implant are incorporated with disinfectants, antibiotics as well as antimicrobial peptides AMPs. This paper is an attempt to review all the antibiotic coatings available for a titanium implant and discuss their prospective future to prevent peri-implant infections. How to cite this article Yarramaneni V, Aparna IN, Sachdeva A, Balakrishnan D, Prabhu N. Emerging Antibacterial Coated Dental Implants: A Preventive Measure for Peri-implantitis. World J Dent 2016;7(4):195-198.


2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Kenan Cantekin ◽  
Hüsniye Gümüş

Purpose. The purpose of this study was to evaluate clinical and radiographic findings of treatments using a new hemostatic agent (Ankaferd blood stopper (ABS)), as compared to ferric sulfate (FS), when used as a pulpotomy medicament in primary teeth. Materials and Methods. The primary molars (70) were selected from 35 children aged 4 to 6 years. The teeth were randomized into two groups for pulpotomy with the ABS (n=35) and the FS (n=35) agents. The patients were recalled for clinical and radiographic evaluation at 3-, 6-, 9-, and 12-month intervals. Results. At the 3- and 6-month clinical and radiographic evaluations, total success rates of 100% were observed in each group. In ABS and FS groups, the clinical success rates, however, reduced to 90.9% and 93.9% at the 9-month examination and 84,8% and 90.9% at the 12-month examination, respectively. Similarly, the teeth in the ABS and FS groups had radiographic success rates of 90.9% and 93.9% at 9 months and 84.8% and 87.8% at 12 moths, respectively. Conclusion. Although the findings indicated that ABS agents may be useful agents for pulpotomy medicament, further long-term and comprehensive histological investigations of ABS treatments are necessary.


2020 ◽  
pp. 159101992097625
Author(s):  
Mehmet Onay ◽  
Ali Burak Binboga ◽  
Cetin Murat Altay

Background and purpose The aim of this study was to investigate the feasibility of the shelf technique by analyzing the angle between the two branch orifices and to present its safety and effectiveness compared with that of the double-stent technique. Materials and methods Patients with complex wide-neck bifurcation aneurysms (WNBAs) who underwent stent-assisted coiling (SAC) were reviewed. The study sample was divided into two groups: single SAC (shelf technique) and double SAC. The angle between the lines connecting the superior and inferior points of each branch orifice (α angle) was measured by two neurointerventional radiologists in both groups. The inter- and intraobserver repeatability and consistency of the α angle were assessed. The effect of the α angle on the feasibility of using the shelf technique to treat WNBA was analyzed. Technical and clinical success rates were investigated by comparing both groups. Results Forty-eight patients (32 shelf technique and 16 double-stent technique) were included. There was excellent agreement between the intra- and interobserver repeatability and consistency of α angle measurements. The α angle was smaller in the shelf technique group than in the double-SAC group (p < 0.001). The technical and clinical success rates of both groups were similar based on long-term follow-up (p > 0.05). Conclusion WNBA treatment with the shelf technique is safe and effective. The α angle is a useful parameter to evaluate the performance of the shelf technique. The shelf technique is more suitable for WNBAs with a narrow α angle.


Endoscopy ◽  
2020 ◽  
Author(s):  
Thomas M. Runge ◽  
Austin L. Chiang ◽  
Thomas E. Kowalski ◽  
Theodore W. James ◽  
Todd H. Baron ◽  
...  

Abstract Background Endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) is an alternative to enteroscopy- and laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy. Although short-term results are promising, the long-term outcomes are not known. The aims of this study were: (1) to determine the rates of long-term adverse events after EDGE, with a focus on rates of persistent gastrogastric or jejunogastric fistula; (2) to identify predictors of persistent fistula; (3) to assess the outcomes of endoscopic closure when persistent fistula is encountered. Methods This was a multicenter retrospective study involving 13 centers between February 2015 and March 2019. Adverse events were defined according to the ASGE lexicon. Persistent fistula was defined as an upper gastrointestinal series or esophagogastroduodenoscopy showing evidence of fistula. Results 178 patients (mean age 58 years, 79 % women) underwent EDGE. Technical success was achieved in 98 % of cases (175/178), with a mean procedure time of 92 minutes. Periprocedural adverse events occurred in 28 patients (15.7 %; mild 10.1 %, moderate 3.4 %, severe 2.2 %). The four severe adverse events were managed laparoscopically. Persistent fistula was diagnosed in 10 % of those sent for objective testing (9/90). Following identification of a fistula, 5 /9 patients underwent endoscopic closure procedures, which were successful in all cases. Conclusions The EDGE procedure is associated with high clinical success rates and an acceptable risk profile. Persistent fistulas after lumen-apposing stent removal are uncommon, but objective testing is recommended to identify their presence. When persistent fistulas are identified, endoscopic treatment is warranted, and should be successful in closing the fistula.


2021 ◽  
Vol 23 (7) ◽  
Author(s):  
Harshit S. Khara ◽  
Swetha Parvataneni ◽  
Steven Park ◽  
Jihye Choi ◽  
Truptesh H. Kothari ◽  
...  

Abstract Purpose of Review Hepatobiliary complications are common in Roux-en-Y gastric bypass (RYGB) patients. Despite development of multiple surgical and endoscopic access techniques over the years, ERCP using standard duodenoscope remains challenging in these patients due to the altered anatomy. Recent Findings Limited success with enteroscope-assisted and laparoscope-assisted ERCP led to the evolution of the novel EUS-directed transgastric ERCP (EDGE) procedure, with variations of this technique termed as Gastric Access Temporary for Endoscopy (GATE), EUS-guided TransGastric ERCP (EUS-TG-ERCP), EUS-guided GastroGastrostomy-assisted ERCP (EUS-GG-ERCP), and EUS-directed transgastric intervention (EDGI). EDGE has high technical (100%) and clinical success rates (60–100%), lower adverse event rate (1.5–7.6%), and up to 20% access stent migration rate; without any significant weight changes. EDGE has significantly shorter procedure time (73vs184min), post-procedural hospital stays (0.8vs2.65 days) and is more cost effective compared to other modalities. Summary EDGE technique addresses the challenges of RYGB anatomy as a minimally invasive, clinically successful, fully endoscopic, and cost-effective option. We present a literature review of the EDGE technique from its inception to current, in addition to reviewing other access techniques, their advantages, disadvantages and outcomes.


2021 ◽  
Author(s):  
Hyeon-Jong Lee ◽  
Dong-Soon Choi ◽  
Insan Jang ◽  
Bong-Kuen Cha

ABSTRACT Objectives To investigate long-term outcomes of dentoskeletal changes induced by facemask therapy using skeletal anchorage in Class III patients and compare them to those of conventional tooth-borne anchorage. Materials and Methods This retrospective study included 20 patients who received facemask (FM) therapy with miniplates as anchorage for maxillary protraction (Miniplate/FM group, 10.6 ± 1.1 years old [mean ± SD]) and 23 patients who were treated with facemask with rapid maxillary expander (RME/FM group, 10.0 ± 1.5 years old [mean ± SD]). Dentoskeletal changes were evaluated using lateral cephalograms at pretreatment (T1), after facemask therapy (T2), and at the post-pubertal stage (T3). Cephalometric changes were compared between groups and clinical success rates at T3 were evaluated. Results SNA and A to N perpendicular to FH increased significantly more in the Miniplate/FM group than in the RME/FM group when comparing short-term effects of facemask therapy (T1–T2). ANB, Wits appraisal, Angle of convexity, mandibular plane angle, and overjet decreased significantly more in the RME/FM group than in the Miniplate/FM group after facemask therapy (T2–T3). A more favorable intermaxillary relationship was observed in the Miniplate/FM group than in the RME/FM group in long-term observations (T1–T3). Clinical success rate at T3 was 95% in the Miniplate/FM group and 85% in the RME/FM group. Conclusions Facemask therapy with skeletal anchorage showed a greater advancement of the maxilla and more favorable stability for correction of Class III malocclusion in the long-term than conventional facemask therapy with tooth-borne anchorage.


2021 ◽  
Vol 09 (06) ◽  
pp. E756-E766 ◽  
Author(s):  
Oscar Hernandez-Mondragon ◽  
Luis Garcia Contreras ◽  
Omar Michel Pineda ◽  
Geraro Blanco-Velasco ◽  
Enrique Murcio-Pérez

Abstract Backgrounds and study aims Treatment of octogenarian patients with achalasia with conventional treatments is effective but with compromised safety. Biodegradable stents (BS) are promising. We aimed to evaluate their safety, efficacy and clinical outcomes at early, mid and long-term in this population. Patients and methods Naïve or previously-treated achalasic octogenarian patients underwent to BS placement (BSP) between December, 2010 and November, 2011, and were followed-up for 9-years. A strict follow-up was performed. Results Thirty-two patients were included, (17 men [53.1 %]; median age 82 years [78–92]). BSP was performed in all patients. At 9y, 18/32 (56.2 %) completed protocol. Mean BSP time was 37.5±12.1 min and 34.4 % presented thoracic pain. At 1 m, six BS were migrated (18.7 %), requiring a second BSP fixed with hemoclips. At 3 m, twenty-three (72.8 %) completed degradation process. At 6 m, eighteen (56.2 %) presented clinical dysphagia, of whom 5/32 (15.6 %) presented stenotic-tissue hyperplasia, responding to balloon dilation in all cases. Pre-BSP Eckardt, Timed barium esophagram and integrated relaxation pressure improved post-BSP 6 m values (9 vs 2, p = 0.001; < 50 % = 93.8 % vs > 80 % = 81.5 %, p = 0.003 and 18.8 ± 3.2 vs 11.1 ± 2.6 mmHg, p = 0.001, respectively), and there were no significant changes up to 9y post-BSP. Esophagitis grade A or B was presented between 4.7 % to 11.2 % and controlled with PPI. After 9 years we had clinical success rates of 94.4 %, 72 %, and 65.4 % for time point evaluation, per protocol and intention to treat analysis, respectively. Conclusions BSP represents a feasible alternative option in octogenarian patients with achalasia who are high risk with other treatments, presenting acceptable early, mid-, and long-term outcomes.


2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Daisuke Uchida ◽  
Hironari Kato ◽  
Yosuke Saragai ◽  
Saimon Takada ◽  
Sho Mizukawa ◽  
...  

Background and Aims. Recurrent pancreatitis associated with pancreatic strictures requires treatment with endoscopic retrograde pancreatography (ERP), but it is sometimes technically unsuccessful. Endoscopic ultrasound-guided pancreatic drainage (EUS-PD) was developed as an alternative to a surgical approach after failed ERP; however, the indications for EUS-PD are unclear. In this study, we evaluated the outcomes of EUS-PD and established the indications for EUS-PD. Methods. A total of 15 patients had indications for EUS-PD for recurrent pancreatitis due to pancreatic strictures. There were eight patients with benign pancreatic strictures and seven with malignant pancreatic strictures. The success rate, adverse events, and long-term outcomes were evaluated. Results. The technical success rates of benign and malignant strictures were 75% (6/8) and 100% (7/7), respectively, and clinical success was achieved in 100% (6/6) and 87.5% of cases (6/7), respectively. Rendezvous procedures were performed in two patients with benign strictures. The adverse event (AE) rate was 26.7% (4/15) and included cases of peritonitis, bleeding, and stent migration. Reinterventions were performed in three patients with benign strictures and two with malignant strictures. Conclusions. EUS-PD was an appropriate treatment for not only benign strictures but also malignant strictures with recurrent pancreatitis after failed ERP. However, the AE rate was high, and reinterventions were required in some cases during long-term follow-up. The indications for EUS-PD should be considered carefully, and careful follow-up is needed.


Sign in / Sign up

Export Citation Format

Share Document