Clip Device Research Articles

Evaluating no fixation, endoscopic suture fixation, and an over-the-scope clip for anchoring fully covered self-expanding metal stents in benign upper gastrointestinal conditions: a comparative multicenter international study (With Video)

Fully covered self-expandable metal stents (FCSEMSs) are widely used in benign upper gastrointestinal (GI) conditions, but stent migration remains a limitation. An over-the-scope clip (OTSC) device (Stentfix {SF], Ovesco Endoscopy) for stent anchoring has recently been developed. The aim of this study was to evaluate the effect of OTSC fixation on FCSEMS migration rate. In this retrospective review of consecutive patients who underwent FCSEMS placement for benign upper GI conditions from January 2011 to October 2022 at 16 centers, the primary outcome was rate of stent migration. The secondary outcomes were clinical success and adverse events. A total of 311 (no fixation [NF] 122, SF 94, endoscopic suturing [ES] 95) patients underwent 316 stenting procedures. Compared with the NF group (n= 49, 39%), the rates of stent migration were significantly lower in the SF (n= 16, 17%, P= .001) and ES (n= 23, 24%, P= .01) groups. The rates of stent migration were not different between the SF and ES groups (P= .2). On multivariate analysis, SF (odds ratio [OR], 0.34, 95% CI, 0.17-0.70, P< .01) and ES (OR, 0.46, 95% CI, 0.23-0.91; P= .02) were independently associated with decreased risk of stent migration. Compared with the NF group (n= 64; 52%), there were higher rates of clinical success in the SF (n= 64; 68%; P= .03) and ES (n= 66; 69%; P= .02) groups. There was no significant difference in the rates of adverse events among the 3 groups. Stent fixation using OTSCs is safe and effective at preventing stent migration and may also result in improved clinical response.

Novel sizing role of 3D transesophageal echocardiography in a novel left atrial appendage clip device for patients undergoing video-assisted atrial fibrillation ablation: a cohort study.

Three-dimensional (3D) transesophageal echocardiography (TEE) has been successfully used in the sizing of left atrial appendage (LAA) occlusion devices, but its use has not yet been studied in LAA clip devices. We sought to develop and validate the novel use of 3D-TEE sizing in a novel LAA clip device for atrial fibrillation (AF) patients undergoing video-assisted thoracic surgery (VATS) ablation. Consecutive patients with isolated AF undergoing LAA clipping or excision during VATS ablation were included in the study between June 2021 and September 2022 at Fuwai Hospital. The patients underwent 3D-TEE examinations preoperatively and postoperatively. The VATS length, LAA clip effective length, and LAA excision margin length were recorded. A correlation analysis, intraclass correlation coefficient (ICC) analysis, and Bland-Altman plot analysis were conducted to examine the TEE parameters, VATS length, LAA clip effective length, and LAA excision margin length. In total, 26 AF patients undergoing LAA clipping and 15 undergoing LAA excision were included in the study. In the LAA clipping group, in which the Atriclip size served as the control, the 3D-TEE with volumetric measurement (the perimeter-derived maximum orifice diameter) (R=0.938; ICC =0.934; Bland-Altman plot variability, 3.85%) showed the best sizing efficacy for the LAA clip device among the 3D-TEE with multiplanar reformatting sizing (the perimeter-derived maximum orifice diameter) (R=0.808; ICC =0.772; Bland-Altman plot variability, 3.85%), VATS sizing (R=0.851; ICC =0.756; Bland-Altman plot variability, 11.54%), and VATS plus 0.5-cm sizing (R=0.851; ICC =0.775; Bland-Altman plot variability, 11.54%) measurements (all P<0.001). In addition, for the distribution of matched sizing in the LAA clip group, 3D-TEE with volumetric measurement sizing (20/26) had a higher proportion than 3D-TEE with multiplanar reformatting sizing (11/26, P=0.011), VATS sizing (9/26, P=0.002), and VATS plus 0.5-cm sizing (14/26, P=0.08). Using the LAA excision margin length as the control, the mean difference in the LAA diameter was 1.17 cm [95% confidence interval (CI): 0.71-1.62 cm , P<0.001] in the maximum orifice diameter of two-dimensional-TEE, 0.15 cm (95% CI: -0.32 to 0.61 cm , P=0.523) in the perimeter-derived 3D multiplanar reformatting (the maximum orifice diameter), and 0.03 cm (95% CI: -0.47 to 0.53, P=0.901) in the perimeter-derived 3D volumetric (3DV) measurement (the maximum orifice diameter), and the related Pearson correlation coefficients for these modalities were 0.760 (P=0.001), 0.843 (P<0.001), and 0.963 (P<0.001), respectively. Our study showed that 3D-TEE might be employed in the sizing of a novel LAA clip device using the VATS approach in patients with AF. The 3DV measurement (the perimeter-derived maximum orifice diameter) was superior to the VATS measurement. These findings might also apply to LAA VATS excision patients with AF.

Abstract 18651: Case Report: Transcatheter Edge-to-Edge Repair in a 59-Year-Old Patient With Mitral Regurgitation and Challenging Anatomy

Re-intervention for patients with mitral valve disease is a growing challenge. We present a 59-year-old male with a history of a congenitally bicuspid aortic valve. He had valve and root replacement for aortic regurgitation in his 30s and two subsequent sternotomies for prosthesis failure and endocarditis. After admission with acute pulmonary edema, there was persistent NYHA class II-III dyspnea. Echo showed severe (grade IV) mitral regurgitation due to the dehiscence of a 32mm mitral annuloplasty ring. The coaptation point of the leaflets was posterior to the posterior aspect of the ring. No regurgitation was observed through the ring’s central orifice, but the tissue was seen on its posterior aspect, suggesting torn posterior leaflet or healed vegetation. The left ventricle was mildly dilated, and the LVEF was 53%. The right ventricle was moderately dilated with severe functional tricuspid regurgitation with a normally functioning aortic valve prosthesis. After extensive discussion, due to his multiple previous surgeries and challenging anatomy, the patient was deemed unsuitable for surgical treatment. There is some limited registry data to support TEER as a safe and feasible alternative to surgery in this cohort. He underwent successful implantation of two clip devices in the A2/P2 and A2/P2b positions via a trans-septal approach under a general anesthetic. Femoral venous access was used. Some useful learning points relate to the challenges posed by the unusual anatomy in terms of imaging and trajectory. No MVARC complications. Postoperatively the LVEF was 55% with a mean transvalvular gradient of 5mmHg and only mild (grade I) transvalvular MR. At three months the patient reported an improvement of overall functional status. This successful case of “clip-in-ring” TEER illustrates one of the expanding indications for existing trans-catheter valvular therapies as well as the potential for creative application of TEER in helping patients with high surgical risk.

Peroperative administration of tranexamic acid in sleeve gastrectomy to reduce hemorrhage: a double-blind randomized controlled trial

IntroductionIn metabolic surgery, hemorrhage is the most common major complication. This study investigated whether peroperative administration of tranexamic acid (TXA) reduced the risk of hemorrhage in patients undergoing laparoscopic sleeve gastrectomy (SG).MethodsIn this double-blind randomized controlled trial, patients undergoing primary SG in a high-volume bariatric hospital were randomized (1:1) to receive 1500-mg TXA or placebo peroperatively. Primary outcome measure was peroperative staple line reinforcement using hemostatic clips. Secondary outcome measures were peroperative fibrin sealant use and blood loss, postoperative hemoglobin, heart rate, pain, major and minor complications, length of hospital stay (LOS), side effects of TXA (i.e., venous thrombotic event (VTE)) and mortality.ResultsIn total, 101 patients were analyzed and received TXA (n = 49) or placebo (n = 52). There was no statistically significant difference in hemostatic clip devices used in both groups (69% versus 83%, p = 0.161). TXA administration showed significant positive changes in hemoglobin levels (millimoles per Liter; 0.55 versus 0.80, p = 0.013), in heart rate (beats per minute; -4.6 versus 2.5; p = 0.013), in minor complications (Clavien–Dindo ≤ 2, 2.0% versus 17.3%, p = 0.016), and in mean LOS (hours; 30.8 versus 36.7, p = 0.013). One patient in the placebo-group underwent radiological intervention for postoperative hemorrhage. No VTE or mortality was reported.ConclusionThis study did not demonstrate a statistically significant difference in use of hemostatic clip devices and major complications after peroperative administration of TXA. However, TXA seems to have positive effects on clinical parameters, minor complications, and LOS in patients undergoing SG, without increasing the risk of VTE. Larger studies are needed to investigate the effect of TXA on postoperative major complications.Graphical abstract

Surgically Induced Astigmatism after Deep Sclerectomy with Esnoper Clip Device Implantation

Purpose: The aim of the study was to evaluate the level of Surgically Induced Astigmatism (SIA) after deep sclerectomy with Esnoper Clip device implantation. Method: We retrospectively evaluated 48 eyes of 41 patients with glaucoma, who underwent deep sclerectomy with Esnoper Clip device (AJL Ophthalmics) implantation between the years 2018-2020 in our clinic. One experienced surgeon performed all surgeries.

Iatrogenic perforation during lumen-apposing metal stent deployment closed using an over-the-scope stent fixation clip device

Video 1Endoscopic closure of an iatrogenic perforation caused during EUS-guided gastrojejunostomy for malignant gastric outlet obstruction treated with an over-the-scope stent fixation clip device.

Left atrial function after standalone totally thoracoscopic left atrial appendage exclusion in atrial fibrillation patients with absolute contraindication to oral anticoagulation therapy.

Left atrial appendage (LAA) is a common source of thrombi in patients with atrial fibrillation (AF). The effect on left atrial (LA) function of the Totally Thoracoscopic (TT)-LAA exclusion with epicardial clip is currently unknown. This study aims at evaluating the effect of TT-LAA exclusion on LA function. Standalone TT-LAA exclusion with the clip device was performed in 26 patients with AF and contraindication to oral anticoagulation (OAC). A 3D CT scan, trans-esophageal echocardiography, spirometry and cerebrovascular doppler ultrasound were performed preoperatively. Clip positioning and LAA exclusion were guided and confirmed by intraoperative trans-esophageal echo. To evaluate LA function, standard transthoracic echocardiography and 2D strain of LA were performed before surgery, at discharge and at 3-month follow-up. The mean CHA2DS2-VASc and HASBLED scores were 4.6 and 2.4 respectively. There were no major complications during the procedure. At median follow-up of 10.3 months, 1 (3.8%) non-cardiovascular death, 1 (3.8%) stroke and 4 (15.4%) cardiovascular hospitalizations occurred. At 2D strain of LA, the reservoir function decreased significantly at discharge, compared to baseline and recovered at 3-months follow-up. Furthermore, NT-proBNP increased significantly after the procedure with a return to baseline after 3 months. Changes in E/A were persistent at 3 months. Our data in a small cohort suggest that TT-LAA exclusion with epicardial clip can be a safe procedure with regards to the atrial function. The LAA amputation impairs the reservoir LA function on the short term, that recovers over time.

Anterior Pathway for Epicardial Left Atrial Appendage Clip Occlusion During Minimally Invasive Atrioventricular Valve Surgery.

The left atrial appendage occlusion (LAAO) by endocardial suture is sometimes inadequate and thrombogenic with uncertain electrical competence. Moreover, epicardial LAAO clip placement through the transverse sinus can be technically challenging during minimally invasive atrioventricular valve surgery. Here, we describe our new endoscopic technique via an anterior access pathway in 5 patients with concomitant atrial fibrillation using an epicardial clip device (AtriClip Pro 1 or AtriClip Pro 2, AtriCure, Mason, OH, USA) for LAAO. The LAAO was successful in all patients without residual perfusion and surgical complications. Epicardial LAAO by clip via the anterior access pathway represents a novel and feasible endoscopic technique for minimally invasive atrioventricular valve surgery.

Endoscopic Repair of an Anastomotic Leak Using Over-the-Scope Clip

Gastrointestinal leaks are a serious surgical complication resulting in communication of intra and extra-luminal compartments arising from a defect in the anastomosis. Here we present a short case with relevant endoscopic images and radiographs demonstrating successful closure of a leak with the over-the-scope clip device. As part of a multidisciplinary team, hospitalists should be familiar with novel endoscopic treatment options.

The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Anorectal Abscess, Fistula-in-Ano, and Rectovaginal Fistula.

The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Anorectal Abscess, Fistula-in-Ano, and Rectovaginal Fistula.

The Sutureless Excimer Laser Anastomosis Clip Pilot Study: a feasibility and safety study

BackgroundThe excimer laser-assisted non-occlusive anastomosis (ELANA) bypass technique may have the advantage of its non-occlusive design in the treatment of last-resort cases where endovascular treatment or direct clipping is considered to be unsafe. However, the technique remains technically challenging. Therefore, a sutureless ELANA Clip device (SEcl) was developed to simplify the technique avoiding tedious anastomosis stitching in depth.The present study investigates the clinical feasibility and safety of the SEcl technique.MethodsThree patients with complex and large aneurysms in the anterior circulation were selected after multidisciplinary consensus that the aneurysms were too complex for endovascular or direct clipping treatment options. Bypass surgery was considered as a last-resort treatment option, and after preoperative evaluation and informed consent, SEcl bypass surgery was performed. Applicability, technical aspects and patient outcomes are assessed.ResultsAll aneurysms were excluded from the circulation. The creation of the intracranial anastomosis was easier and faster. No device-related serious adverse events were encountered, and all outcomes were favorable (one patient stable Modified Rankin Scale, two patients improved).ConclusionThe SEcl anastomosis technique is feasible and, considering the severity of the disease, relatively safe. It can be considered a treatment option in very difficult-to treat last-resort aneurysm cases. From this study, further developments in minimizing clip size and application in cardiac surgery are initiated.

Factors contributing to changes in viscosity and flow rate of a dedicated gel for gel immersion endoscopy.

Background and study aims Gel immersion endoscopy is a novel technique for securing the visual field during endoscopy. Clinical application of a dedicated gel for this technique with an appropriate viscosity to prevent mixing with blood and its efficacy was reported. The aim of this study was to evaluate changes in gel viscosity and flow rate under different conditions. Methods The viscosity of the gel after injection and flow rate were measured under various conditions changing the injection route and method. Gel viscosity was measured at 25, 10, and 4 °C. Results A decrease in gel viscosity was found when the gel was injected via the water jet channel compared to the accessory channel. The flow rate and decrease in viscosity of the gel injected via the water jet channel were 220 mL/min and 63.2 %, while when injected via the accessory channel with a clip device inserted were 560 mL/min and 35.8 %. When the gel was kept at a low temperature, the viscosity increased. Conclusions Gel injection via the accessory channel should be the first choice for efficient use considering the viscosity and flow rate.

Reduction of esophageal stent migration rate with a novel over-the-scope fixation device (with video)

Self-expandable metal stent (SEMS) placement is routinely performed in a variety of benign and malignant GI diseases. One of the most frequent adverse events after esophageal SEMS placement is stent migration. We evaluated a novel over-the-scope clip device (stentfix OTSC; Ovesco Endoscopy, Tuebingen, Germany) designed and approved for SEMS fixation. This single-center retrospective observational cohort study was performed to analyze stent migration ratesbefore and after availability of the stentfix OTSC device. A cohort of patients who consecutively underwent SEMS fixation with the stentfix OTSC system (SF cohort) was compared with an historical cohort of patients who did not receive stentfix OTSC fixation or any other stent fixation method (NF cohort) before the stentfix OTSC system became available. Outcome variables including technical success, adverse events and clinical success were analyzed. Seventy-seven patients (SF cohort, 26; NF cohort, 51) underwent esophageal SEMS implantation for malignant (69%) and benign (31%) conditions. The technical success rate of stent fixation was 100%, and no procedure-related adverse events were observed. The stent migration rate was significantly lower in the SF cohort compared with the NF cohort (8.3% vs 35.4%, P< .001), indicating a relative risk reduction of 76.5% associated with stentfix OTSC application. Stent implantation across the gastroesophageal junction was identified as a predictor of stent migration. In patients with benign or malignant gastroesophageal diseases, there was a significantly lower stent migration rate in patients managed with the stentfix OTSC system compared with those without stent fixation. The application was technically successful in all cases, and no adverse events related to clip application or removal were observed.

Incessant Atrial Tachycardia: Problem Solving With Minimally Invasive Surgery

A 35-year-old female with sarcoidosis sought medical attention due to palpitations. The ECG showed an atrial tachycardia (AT), apparently originating in the left atrium. A 24-hour Holter monitoring revealed AT to be present during the entire day. Cardiac magnetic resonance exhibited no cardiac involvement by sarcoidosis but registered a mildly depressed left ventricular ejection fraction (LVEF). Atrial electroanatomical mapping showed the earliest activation zone on the distal portion of the left atrial appendage (LAA). Considering the high risk for perforation with catheter ablation in this region, she was sent to thoracoscopic surgical LAA exclusion with a clip device; it was possible to witness the termination of the arrhythmia during the procedure. She was safely discharged two days after surgery and has completed a one-year follow-up without recurrence of AT or symptoms, and with normalization of LVEF.

Novel clip device for prevention of bleeding after endoscopic papillectomy.

ObjectivesRecently, a novel clip device, SureClip® (Micro‐Tech Co. Ltd., Nanjing, China), has been developed, which improved rotation and reopening performance. We aimed to assess the efficacy of the SureClip® in prophylactic closure of the mucosal break after endoscopic papillectomy (EP) for ampullary neoplasm.MethodsWe retrospectively reviewed the medical records of 40 patients who underwent EP for ampullary neoplasms between October 2009 and March 2020. Prophylactic closure after resection was performed using the conventional clip between 2014 and 2018, and with the SureClip® after 2019. The baseline characteristics, techniques, outcomes, and complications of EP were analyzed.ResultsThe median age of the patients (25 males and 15 females) was 70 years. The en block resection rate was 82.5% and the curative resection rate was 80.0%. Histologically, 11 (27.5%) patients had malignancy. Prophylactic closure was performed in 29 (72.5%) patients (17 conventional clips, 12 SureClip®). Complications occurred in 18 (45.0%) patients, including postprocedure bleeding in 9 (22.5%) patients. However, no postprocedure bleeding was observed in the patients who received prophylactic closure using the SureClip® (p = 0.038). All other factors were not significantly correlated with postprocedure bleeding. The duration of hospital stay after EP was significantly shorter in patients treated with the SureClip® compared to those treated with a conventional clip or without clips (p < 0.05).ConclusionsIn the present study, prophylactic clipping of the mucosal break using the SureClip® was effective in preventing bleeding after EP.

Comparative computational analysis of PASCAL and MitraClip implantation in a patient-specific functional mitral regurgitation model.

Transcatheter mitral leaflet approximation with MitraClip has proven to be a viable treatment option for heart failure patients with functional mitral regurgitation (MR). PASCAL is a similar clip device, but it has design features that differentiate it from MitraClip. The effects of the different clip designs are largely unknown. In this study, using a patient-specific, mitral valve-left ventricle heart model, we performed finite-element (FE) simulations to provide a head-to-head comparison of the post-operative effects that PASCAL and MitraClip have on mitral valve (MV) geometry and biomechanics in a functional MR patient. The two devices were modeled as approximations of the real devices, and three implantation configurations were simulated for each device. The results showed that for this patient case, PASCAL caused less MV deformation than MitraClip. Additionally, PASCAL implantation reduced the stresses and strains in the MV leaflets compared to pre-repair conditions, while MitraClip implantation caused them to increase. Although complete coaptation was not achieved, both devices improved leaflet coaptation and were viable MR treatment options. The FE simulations in this study can be used to quantify biomechanics involved in clip treatments and improve our understanding of complex interactions between human hosts and percutaneous clip devices.

Surgical clip closure of the left atrial appendage.

Atrial fibrillation (AF) is the most common atrial arrhythmia, but it is not a benign disease. AF is an important risk factor for thromboembolic events, causing significant morbidity and mortality. The left atrial appendage (LAA) plays an important role in thrombus formation, but the ideal management of the LAA remains a topic of debate. The increasing popularity of surgical epicardial ablation and hybrid endoepicardial ablation approaches, especially in patients with a more advanced diseased substrate, has increased interest in epicardial LAA management. Minimally invasive treatment options for the LAA offer a unique opportunity to close the LAA with a clip device. This review highlights morphologic, electrophysiologic, and surgical aspects of the LAA with regard to AF surgery, and aims to illustrate the importance of surgical clip closure of the LAA.

Robotics-assisted epicardial left atrial appendage clip exclusion.

ObjectivesWe demonstrate the feasibility and safety of robotics-assisted left atrial appendage clip exclusion in clinical practice.MethodsAnalysis of a single center robotics-assisted left atrial appendage clip exclusion experience using an epicardial linear clip device in patients with atrial fibrillation with high-risk of thromboembolic stroke and intolerance to oral anticoagulants.ResultsDuring the period from December 2017 to September 2020, we performed 42 robotics-assisted left atrial appendage clip exclusions in response to increased risk of bleeding in patients with atrial fibrillation and intolerance to oral anticoagulants. The average congestive heart failure, hypertension, age, diabetes, stroke, and vascular disease score was 5.2 ± 1.6 and hypertension, abnormal liver or kidney function, stroke, bleeding, labile international normalized ratio, elderly, drugs (aspirin, other antiplatelets, or anticoagulants) score was 4.5 ± 0.9. No patients died intraoperatively or within 30 days, or due to conversion to thoracotomy, intraoperative complications, or failure to apply the clip satisfactorily. The procedure was successfully completed despite pericardial adhesions in 2 patients with prior coronary bypass grafts and 3 with postpericarditis scars. Intraoperative transesophageal echocardiography was performed in 38 out of 42 patients; satisfactory exclusion with left atrial appendage stump <5 mm was confirmed in all. Average length of stay was 3.4 ± 3 days with 12 out of 42 patients discharged within 24 hours. Oral anticoagulants were discontinued in 41 out of 42 patients and no cases of 30-day stroke, myocardial ischemia, or new arrhythmias were observed. One case of hemothorax required thoracoscopy a day later. There was no reported thromboembolic stroke or transient ischemic attack at 12 months. One case of late lacunar stroke was due to in situ small intracranial vessel thrombosis without left atrial appendage thrombus on imaging.ConclusionsRobotics-assisted left atrial appendage clip exclusion is a safe and feasible minimally invasive method for left atrial appendage management in patients with atrial fibrillation with intolerance to oral anticoagulants and increased risk of thromboembolic stroke.

How to Perform a High-Quality Endoscopic Submucosal Dissection

How to Perform a High-Quality Endoscopic Submucosal Dissection

Revealing the scope of surgical device malfunctions: Analysis of the “hidden” Food and Drug Administration device database

BackgroundWe compared surgical device malfunction reports in the Food and Drug Administration (FDA) public Manufacturer and User Facility Device Experience (MAUDE) with those in the FDA nonpublic Alternative Summary Reporting (ASR). MethodsGeneral surgery device product code categories in MAUDE and ASR from 1999 to 2018 were identified. Changes in the rates of categories and adverse events were evaluated by Poisson regression. ResultsThere were 283,308 (72%) general surgical device malfunctions in MAUDE and 109,954 (28%) in ASR. Reports increased annually in ASR versus MAUDE, particularly for surgical staplers and clip devices (p < 0.05). ASR contained approximately 80% of these reports; MAUDE 20%. In MAUDE, 42.9% of surgical device malfunctions and 20.2% of stapler/clip malfunctions resulted in patient injury or death. ASR listed no injury or death information. ConclusionsASR contained a significant portion of surgical device malfunctions hidden from public scrutiny. Access to such data is essential to safe surgical care.