Suturing System Research Articles

Efficacy and safety of the OverStitch endoscopic suturing device for closure of defects after endoscopic submucosal dissection: a systematic review and meta-analysis

Background and AimsEndoscopic submucosal dissection (ESD) is used for closure of gastrointestinal (GI) lesions following endoscopic resection techniques such as endoscopic mucosal resection. Generally, a large defect is left that can increase the risk of postprocedural bleeding or perforation, and has been managed by techniques such as endoscopic placement of clips to reapproximate the defect edges. An over the scope suturing system (OSS), Overstitch created by Apollo endosurgery, has been designed for similar utility in ESD closure. Its design intent aimed for full thickness closure and exchange of suture without endoscopic removal. This paper aims to evaluate the technical success and efficacy of use of OSS in the closure of ESD. MethodsA comprehensive literature review across multiple databases was performed. Studies including Overstitch and ESD information were evaluated, with 7 articles meeting predetermined eligibility of quality for inclusion. Statistical analysis was completed using CMV v 3.0 software. The primary evaluated endpoint was technical success and efficacy of instrument use in patients undergoing ESD closure with OSS. The secondary evaluated endpoint was the overall rate of adverse events related to the use of OSS. ResultsOverall, the pooled rates for instrumental efficacy and technical success were 95.8% (95% CI: 80.6%, 99.2%; P=0.04) and 99.2% (95% CI: 79.8%, 100.0%; P=1.00), respectively. The pooled rate of adverse events was 0.9% (95% CI: 0.0%, 24.8%; P=0.99) with pain reported as the most common adverse event. ConclusionsThe OSS system appears to be an effective and safe tool in the closure of defects after ESD. However, its design also makes it quite large and difficult to maneuver. While it allows for replacement of the suture kit without endoscopic removal, there have been multiple reported episodes of device failure. Further randomized controlled trials warranted as OSS becomes more widely used.

Preliminary validation of the virtual bariatric endoscopic simulator

Background and AimsObesity is a global health concern. Bariatric surgery offers reliably effective and durable weight loss and improvements of other comorbid conditions. However, the accessibility of bariatric surgery remains limited. Minimally invasive techniques, including endoscopic sleeve gastroplasty (ESG), have emerged to bridge this gap. To effectively complete the ESG procedure, one requires skill in multiple complex interventional endoscopic maneuvers. This requisite expertise poses challenges for training in this burgeoning field. MethodsWe designed the Virtual Bariatric Endoscopic (ViBE) simulator software to mimic the ESG procedure accurately. It features a detailed simulation of an endoscope equipped with an endoscopic suturing system and a high-resolution stomach, enhancing the visualization of the procedural details. Furthermore, it incorporates performance metrics utilizing a reverse scoring system to evaluate users’ proficiency in tasks such as argon plasma coagulation (APC) marking, suturing, and cinching. To validate the simulator, we conducted a study involving experts and novices at the Indiana University School of Medicine, where participants engaged with the simulation environment in a series of training tasks. ResultsTwelve participants, comprising five experts and seven novices, participated in the study. They were asked to complete a post-questionnaire featuring seven items, rating each on a Likert scale. The APC task realism received the highest score, averaging 3.83. The usefulness of improving endoscopic technical skills averaged 3.08, with the realism of cinching the knot and suturing tasks receiving scores of 3.17 and 3.25, respectively, suggesting a generally positive reception. Automated performance metrics indicated that, on average, experts outperformed novices by 10.83 points. ConclusionThe ViBE simulation strives to replicate the steps of the ESG within a virtual environment. Our primary objective in developing this simulator is to enhance the learning curve for endoscopic suturing and ESG techniques, thereby safely extending these skills to a broader patient base.

Efficacy and Safety of Endoscopic Through-the-Scope Suture System for Gastrointestinal Defects: A Systematic Review and Meta-analysis.

Recently, a through-the-scope suturing (TTSS) system has received FDA approval and has been evaluated for closing mucosal defects postintervention. We hereby performed a systematic review and pooled meta-analysis of available studies to assess the safety and efficacy of this intervention. We queried the following databases through April 26, 2023: Embase, MEDLINE, Cochrane Central Register of Controlled Trials, and Web of Science Core Collection. Endoscopists utilizing TTSS for the following reasons were included: endoscopic mucosal resection, endoscopic submucosal dissection, peroral endoscopic myotomy, perforation, fistula closure, and/or stent fixation. The outcomes assessed were technical success, primary clinical success (closure of defect without additional intervention), and overall clinical success (closure of defect with/without additional intervention). Random effects model with the DerSimonian Laird approach was used to report event rates expressed as proportions with a 95% CI. A total of 12 studies with 512 patients (mean age of 61.5 ± 18.4y, 54.6% females) were included. The technical success rate was 96.0% (CI: 94.3%-97.7%). The primary clinical success rate was 74.8% (CI: 65.5%-84.1%). The overall clinical success rate was 95.4% (CI: 92.6-98.2%). Only 1 mortality case unrelated to intervention was reported. The TTSS appears safe and effective for closing mucosal defects after therapeutic endoscopic interventions. Further cost-effective studies should be performed comparing with endoclips for use in clinical settings.

Innovative Mitral Valve Repair Using a Novel Automated Suturing System: Preliminary Data.

(1) Background and Objectives: Mitral regurgitation is a common valve disease requiring surgical repair. Even with satisfactory results, repair techniques may underlie subjectivity and variability and require long learning curves. A novel approach, the "Roman Arch" technique, may ease the technical burden. This study assessed an automated suturing device's feasibility and time efficiency for a proposed simplified technique. (2) Materials and Methods: Using the MiStitch™ and MiKnot™ devices (LSI Solutions, Inc., Victor, NY, USA), the suture pattern was performed in a cadaver model. Three surgeons with different expertise levels conducted the procedures. Repair and suture placement times were recorded and analyzed. (3) Results: The modified "Roman Arch" repair was completed on all ten human heart specimens with an average total repair time of 3:01 ± 00:59 min and a trend toward reduced times as experience increased. The study confirmed the technical feasibility with 90% of the attempts rated as rather satisfactory or very satisfactory. (4) Conclusions: The MiStitch™ system effectively facilitated the modified "Roman Arch" repair in an ex vivo setting, suggesting its potential to reduce the technical complexity of mitral valve repairs. Further studies are needed to confirm its efficacy and safety in clinical practice.

Endoscopic suturing system is the last chance for rectal bleeding after complicated endoscopic submucosal dissection.

Endoscopic suturing system is the last chance for rectal bleeding after complicated endoscopic submucosal dissection.

Whipstitch and Locking Stitch Show Equivalent Elongation and Load to Failure Across 3 Suture Systems in a Biomechanical Model of Quadriceps Tendon Grafts for Anterior Cruciate Ligament Reconstruction

PurposeThe purpose of this study was to compare the biomechanical properties of quadriceps tendon (QT) graft stitch methods using three different suture systems for anterior cruciate ligament (ACL) reconstruction. MethodsA total of 48 QTs were harvested from cadaveric knee specimens (age: 73 ± 7 years; range 66-86 years). Samples were randomly divided into three groups where different suture needle systems were used to create two stitch methods: whip stitch (WS) and locking stitch (LS). Surgeons performed each technique to five stitches, each 0.5cm apart. Stitching time was recorded. Samples were pre-conditioned then underwent cyclic loading, followed by load-to-failure. Stiffness (N/mm), ultimate failure load (N), peak-to-peak displacement (mm), elongation (mm), and failure displacement (mm) were recorded. ResultsWS and LS were equivalent across stiffness, ultimate load and peak to peak displacement within Groups 2 and 3. In Group 1, the LS was stiffer than the WS, however the WS achieved a higher ultimate load. For all Groups, the LS achieved lower elongation and failure displacement than the WS, with significant differences in Group 1 and 2. Within each stitching method, equivalence was determined for total elongation and ultimate failure load for all three suture system groups. For WS samples, Group 1 all failed from suture breakage, and both Groups 2 and 3 had instances of failure from suture pull through. All LS samples failed from suture breakage. ConclusionBoth LS and WS provide adequate mechanical properties in each of the three suture systems. Differences in performance do exist; however, each method shows equivalent total elongation and ultimate failure load for all three suture systems. LS may be preferred versus WS due to lower mean elongation and failure displacement. Clinical RelevanceThere is an increased use of a quadriceps tendon (QT) grafts in ACL reconstruction. However, there has been a limited number of studies comparing various stitching methods and optimizing techniques for QT graft fixation. This study may provide important information to surgeons about which suture techniques have better biomechanical profiles.

Relationship Between Circummaxillary and Intramaxillary Suture Densities and Skeletal Effects of Rapid Maxillary Expansion.

This retrospective clinical study aimed to evaluate the maturation of intramaxillary and circummaxillary suture systems and cervical vertebral maturation as predictors of the skeletal response achieved by rapid maxillary expansion (RME). A Digital Imaging and Communication in Medicine dataset of 20 patients (mean age: 15.55 years) prior (T0) and after (T1: 3.5±0.5 months) to RME were retrieved from the archive and analyzed. Bone density values of midpalatal suture (MPS), zygomaticomaxillary suture (ZMS), zygomaticotemporal suture (ZTS), pterygopalatine suture (PPS), and transverse palatine suture (TPS) were measured. The cervical vertebral maturational stages (CVS) were examined. The linear distances between the most lateral points of the piriform apertures were measured as the anterior reference, and the medial margins of the greater palatine foramina on the axial slice were chosen as the posterior reference. The difference at T1-T0 was calculated as the skeletal response to RME at anterior and posterior skeletal references. Spearman's rho rank and Kruskal-Wallis tests were used. Mean density values of ZMS, PPS, ZTS, TPS, MPS-Anterior, and MPS-Posterior were 922.81, 807.44, 753.83, 640.77, 661.13, and 604.59 HU, respectively. Mean linear changes in anterior and posterior skeletal expansion were 2.93±1.78 and 1.93±2.52 mm. There was no significant relationship between maturation indicators and skeletal response. Significant relationships were found between CVS and MPS density and CVS and circummaxillary suture average density (p≤0.05). Sutural density showed significant variations among CVSs. Although there was no correlation between skeletal response and density measurements, sutural density was found to be a promising indicator for future studies.

Long-term results after transoral outlet reduction (TORe) of the gastrojejunal anastomosis for secondary weight regain and dumping syndrome after Roux-en-Y gastric bypass.

Bariatric surgery has been proven to be the most effective therapy for obesity and Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed procedure. However, weight regain and dumping syndrome occur over time. The transoral outlet reduction (TORe) procedure using an endoscopic suturing device may be an option to treat these conditions. We aimed to analyze outcome parameters and long-term results for this endoscopic technique. A retrospective data analysis of patients who underwent TORe using an endoscopic suturing system at our institution from January 2015 to December 2020 was performed. A total of 71 subjects were included. Forty-five patients received the intervention for weight regain, 9 for dumping syndrome and 17 for both. The primary endpoint was weight stabilization or weight loss for subjects with weight regain, and resolution of symptoms for those with dumping syndrome. Secondary endpoints were intraoperative complications, procedure time, length of hospital stay and diameter of gastrojejunal anastomosis 1year post-intervention. The median size of the gastrojejunal anastomosis was estimated at 30mm before intervention, and after performing a median of 3 endoscopic sutures, the median estimated gastrojejunal anastomosis width was reduced to 9.5mm. Eight perioperative complications occurred. Overall mean follow-up was 26.5months. All interventions achieved weight stabilization or weight loss or resolution of dumping symptoms within the first 3months, 98.2% at 12months, 91.4% at 24months and 75.0% at 48months. In 22/26 subjects a persisting improvement of dumping syndrome was achieved. TORe is a safe and effective procedure in the treatment of patients with dumping syndrome after laparoscopic RYGB, the effect on weight stabilization is less significant. A prospective randomized trial should be conducted to compare the effects of TORe with other surgical methods like banding the gastrojejunal anastomosis.

Advancements in Deep Learning for Minimally Invasive Surgery: A Journey through Surgical System Evolution

The surge in artificial intelligence (AI) applications across diverse fields owes much to advancements in deep learning and computational processing speed. In medicine, AI's reach extends to medical image analysis and genomic data interpretation. More recently, AI's role in analyzing minimally invasive surgery (MIS) videos has gained traction, with a growing body of research focusing on organ and anatomy identification, instrument recognition, procedure recognition, surgical phase delineation, surgery duration prediction, optimal incision line identification, and surgical education. Concurrently, the development of autonomous surgical robots, exemplified by the Smart Tissue Autonomous Robot (STAR) and RAVEN systems, has shown promising strides. Notably, STAR is currently employed in laparoscopic imaging to discern the surgical site from laparoscopic images and is undergoing trials for an automated suturing system, albeit in animal models. This review contemplates the prospect of fully autonomous surgical robots in the future.

Advancements in Deep Learning for Minimally Invasive Surgery: A Journey through Surgical System Evolution

The surge in artificial intelligence (AI) applications across diverse fields owes much to advancements in deep learning and computational processing speed. In medicine, AI's reach extends to medical image analysis and genomic data interpretation. More recently, AI's role in analyzing minimally invasive surgery (MIS) videos has gained traction, with a growing body of research focusing on organ and anatomy identification, instrument recognition, procedure recognition, surgical phase delineation, surgery duration prediction, optimal incision line identification, and surgical education. Concurrently, the development of autonomous surgical robots, exemplified by the Smart Tissue Autonomous Robot (STAR) and RAVEN systems, has shown promising strides. Notably, STAR is currently employed in laparoscopic imaging to discern the surgical site from laparoscopic images and is undergoing trials for an automated suturing system, albeit in animal models. This review contemplates the prospect of fully autonomous surgical robots in the future.

Primary anastomosis closure after endoscopic ultrasound-directed transgastric intervention.

Background and study aims Endoscopic ultrasound-directed transgastric intervention (EDGI) is a technique that creates an anastomosis between the gastric pouch or jejunum to the excluded stomach in Roux-en-Y gastric bypass (RYGB) anatomy to allow access to the pancreaticobiliary system. Thus far, management of anastomosis closure at the time of lumen-apposing metal stent (LAMS) removal has varied widely. This study aimed to assess the efficacy of primary closure at the time of LAMS removal using athrough-the-scope (TTS) tack-based suture system. Patients and methods This was a two-center retrospective study of RYGB patients who underwent single-stage EDGI using a 20-mm LAMS and subsequent primary anastomosis closure with the X-tack system at the time of stent removal. Patient demographics, procedure details, clinical outcomes, and imaging findings are reported. Results Nineteen patients (median age 63 years, 84% female) underwent single-stage EDGI with a median follow-up of 31.5 months. Adverse events occurred in two patients (11%) who had abdominal pain requiring hospitalization. The median LAMS dwell time was 32 days (range 16-86). All patients (100%) who underwent follow-up studies after LAMS removal had confirmed anastomosis closure (n = 18). Most patients had documented weight loss at the time of LAMS removal and at last follow-up (68%, n = 13). Conclusions Single-stage EDGI is an effective approach to managing RYGB patients with pancreaticobiliary pathology. Thus far, endoscopic TTS tack-based suturing appears to have a high success rate in anastomosis closure after LAMS removal and should be considered as a primary method for preventing chronic fistulae.

Endoscopic outcomes using a novel through-the-scope tack and suture system for gastrointestinal defect closure: a systematic review and meta-analysis.

Closure of gastrointestinal defects can reduce postprocedural adverse events. Over-the-scope clips and an over-the-scope suturing system are widely available, yet their use may be limited by defect size, location, operator skill level, and need to reinsert the endoscope with the device attached. The introduction of a through-the-scope helix tack suture system (TTSS) allows for closure of large irregular defects using a gastroscope or colonoscope, without the need for endoscope withdrawal. Since its approval 3 years ago, only a handful of studies have explored outcomes using this novel device. Multiple databases were searched for studies looking at TTSS closure from inception until August 2023. The primary outcomes were the success of TTSS alone and TTSS with clips for complete defect closure. Secondary outcomes included complete closure based on procedure type (endoscopic mucosal resection [EMR], endoscopic submucosal dissection [ESD]) and adverse events. Eight studies met the inclusion criteria (449 patients, mean defect size 34.3 mm). Complete defect closure rates for TTSS alone and TTSS with adjunctive clips were 77.2% (95%CI 66.4-85.3; I2=79%) and 95.2% (95%CI 90.3-97.7; I2=42.5%), respectively. Complete defect closure rates for EMR and ESD were 99.2% (95%CI 94.3-99.9; I2 = 0%) and 92.1% (95%CI 85-96; I2=0%), respectively. The adverse event rate was 5.4% (95%CI 2.7-10.3; I2=55%). TTSS is a novel device for closure of postprocedural defects, with relatively high technical and clinical success rates. Comparative studies of closure devices are needed.

Fixation of the proximal flange of a lumen-apposing metal stent using a through-the-scope endoscopic suturing system to prevent stent migration in single-session EUS-directed transgastric ERCP: a pilot study

With the global obesity pandemic, clinical scenarios requiring urgent ERCP in patients with gastric bypass surgery are on the rise, and single-session EUS-directed transgastric ERCP (SS-EDGE) can effectively address these technical challenges. The aim of this study was to evaluate and describe the safe and effective use of a through-the-scope endoscopic suturing system for anchoring the lumen-apposing metal stents (LAMSs) during SS-EDGE. Six patients with Roux-en-Y gastric bypass (RYGB) underwent SS-EDGE at our center. A through-the-scope endoscopic suturing system was used for anchoring the LAMSs during SS-EDGE. Clinical and technical success was achieved in all 6 patients without any adverse events related to the procedure. No stent migration, pneumoperitoneum, or GI perforation was noted. At the 4-week follow-up, no stent migration was noted, and the through-the-scope suturing system remained anchored. LAMSs along with tacks were removed, and gastric fistulae were successfully closed endoscopically in all patients to prevent weight gain. Use of through-the-scope endoscopic suturing can be a safe, reliable, and potentially cost-effective novel technique for LAMS fixation to successfully perform SS-EDGE in RYGB patients.

Highly Elastic, Bioresorbable Polymeric Materials for Stretchable, Transient Electronic Systems

HighlightsThe paper introduces a bioresorbable elastomer, poly(glycolide-co-ε-caprolactone) (PGCL), with remarkable mechanical properties, including high elongation-at-break (< 1300%), resilience, and toughness (75 MJ m−3) for soft and transient electronics.Fabrication of conducting polymers with PGCL yields stretchable, conductive composites for transient electronic devices, functioning reliably under external strains.The study demonstrates the feasibility of a disintegrable electronic suture system with on-demand drug delivery for rapid recovery of post-surgical wounds on soft, time-dynamic tissues or versatile biomedical areas of interest.

Efficacy, Feasibility, and Safety of the X-Tack Endoscopic HeliX Tacking System: A Multicenter Experience.

The application of endoscopic suturing has revolutionized defect closures. Conventional over-the-scope suturing necessitates removal of the scope, placement of the device, and reinsertion. A single channel, single sequence, through-the-scope suturing device has been developed to improve this process. This study aims to describe the efficacy, feasibility, and safety of a through-the-scope suturing device for gastrointestinal defect closure. This was a retrospective multicenter study involving 9 centers of consecutive adult patients who underwent suturing using the X-Tack Endoscopic HeliX Tacking System (Apollo Endosurgery). The primary outcomes were technical success and long-term clinical success. Secondary outcomes included adverse events, recurrence, and reintervention rates. In all, 56 patients (mean age 53.8, 33 women) were included. Suturing indications included fistula repair (n=22), leak repair (n=7), polypectomy defect closure (n=12), peroral endoscopic myotomy (POEM) site closure (n=7), perforation repair (n=6), and ulcers (n=2). Patients were followed at a mean duration of 74 days. Overall technical and long-term clinical success rates were 92.9% and 75%, respectively. Both technical and clinical success rates were 100% for polypectomies, POEM-site closures, and ulcers. Success rates were lower for the repair of fistulas (95.5% technical, 54.5% clinical), leaks (57.1%, 28.6%), and perforations (100%, 66.7%). No immediate adverse events were noted. This novel, through-the-scope endoscopic suturing system, is a safe and feasible method to repair defects that are ≤3cm. The efficacy of this device may be better suited for superficial defects as opposed to full-thickness defects. Larger defects will need more sutures and probably a double closure technique to provide a reinforcement layer.

Limited open repair for achilles tendon rupture in the setting of co-morbidities: A case series and technique review

An acute Achilles tendon rupture poses a difficult treatment strategy in both young and old patients. Commonly considered an injury of the middle aged “weekend warrior,” an Achilles tendon tear in a sedentary patient is quite debilitating. An open surgical repair has many advantages including direct tendon visualization as well as the ability to interlock the suturing technique. Unfortunately, the extensive incision needed for proper tendon exposure creates a tenuous scenario primed for an increased risk of complications. The classic surgical incision disrupts the paratenon, the main blood supply to the watershed area of the tendon at the rupture site which is the weakest point of the repair. The minimal subcutaneous layer between the distal skin incision and the tendon has notoriously been a site of dehiscence. An infection in this area spreads quickly along the tendon planes with devasting consequences. These grave complications have led to a paradigm shift in repair techniques. Minimally invasive procedures utilize a percutaneous jig suturing system placed through a small incision at the site of rupture. Unfortunately, a distinct set of complications are associated with blind placement of fiber wire including sural nerve entrapment and incomplete tendon capture in the repair technique. A new technique merges the advantages of a small incision with the ability to directly visualize the tendon repair. The paratenon is maintained at the rupture site while being able to utilize an asymmetric offset classic suturing technique to add strength to the repair.

Wound Healing Improvement by Polymer Surgical Suture Coated with Tannic Acid

A surgical suture is a vital medical device to uphold wounded tissue during surgery. However, the application to improve tissue healing must still be developed. This study offered to solve this problem by incorporating tannic acid (TA) into polydioxanone (PDS) sutures. The PDS suture was immersed in TA complexing with iron (III) solutions in pH 8.0 solution. The engineered suture was successful, as revealed by the OH peak of TA in FTIR spectra. Furthermore, it was confirmed by TA particle appearance under Scanning Electron Microscopy. Contact angle measurement showed better wettability in biological mimicking solutions, such as water, serum, and saline solution. Thereby, it improved in vitro wound healing activity. Moreover, our bioinformatics data showed that TA enhanced the wound healing process by addressing multiple targets in the early phase of inflammation. For instance, it induced platelets to reduce bleeding at the early wound healing stage, activated T cells at the inflammation stage, accelerated epidermis cell proliferation, and activated fibroblast as a key player in wound healing. Due to multiple wound healing targets, our suture system was expected to be emphasized in clinical applications. HIGHLIGHTS The engineered surgical suture was fabricated by modifying the surface of surgical suture with tannic acid (TA) through iron (III) complex formation in basic condition The modified PDS suture had a high wettability degree of water, saline, and serum, representing the biological fluid, which was expected to have better biocompatibility Based on bioinformatics analysis, TA revealed multiple targets to stop bleeding by activating platelet through FYN, CD4, and CD8 T cells, induced epithelial cells proliferation through Epidermal Growth Factor Receptor (EGFR), and activated many transcription and migration factors of fibroblast GRAPHICAL ABSTRACT

Two-phase kinematic evolution of the Qilian Shan, northern Tibetan Plateau: Initial Eocene−Oligocene deformation that accelerated in the mid-Miocene

The Cenozoic growth of the Tibetan Plateau and the distribution of deformation across it are a consequence of India-Asia collision and continued convergence, which have implications for studies of continental tectonics. The spatio-temporal development of Cenozoic deformation along the northern margin of the plateau is an important issue that can be better understood by testing various models of plateau growth. The northern Tibetan Plateau is bounded by the Cenozoic Qilian Shan thrust belt and the Haiyuan left-slip fault. We conducted geologic mapping, field observations, electron spin resonance (ESR) dating, and apatite (U-Th)/He (AHe) and apatite fission-track (AFT) analysis in the Qilian Shan thrust belt to improve our understanding of the timing of brittle faulting and range exhumation in the northern Tibetan Plateau. We document the first direct age constraints for Oligocene deformation within the central Qilian Shan via ESR dating, which correlates with AHe-AFT cooling ages in adjacent ranges. We demonstrate that the Qilian Shan thrust belt experienced a two-phase growth history, including Eocene−Oligocene fault-related uplift shortly after the India-Asia convergence, and mid-Miocene regional overprinting deformation that reactivated the proximal thrust faults. This deformational pattern suggests that the Qilian Shan thrust belt has experienced out-of-sequence development since the Eocene−Oligocene and has persisted as the stationary northeastern boundary of the Himalayan-Tibetan Orogen throughout the Cenozoic. The Paleozoic Qilian suture systems acted as a pre-existing weakness and played a decisive role in controlling the lithospheric rheology, which therefore impacted the timing, pattern, and strain distribution of Cenozoic deformation across the northern Tibetan Plateau.

Vascular Complications Following Transcatheter Aortic Valve Implantation, Using MANTA (Collagen Plug-Based) versus PROSTAR (Suture-Based), from a French Single-Center Retrospective Registry.

TAVI requires a large-bore arteriotomy. Closure is usually performed by the suture system. Some studies report a vascular complication rate of up to 21%. MANTA is a recently developed percutaneous closure system dedicated to large caliber vessels based on an anchoring system. Early studies report a lower rate of vascular complications with MANTA devices. This single-center retrospective study included all patients who underwent femoral TAVI at the Brest University Hospital from 20 November 2019 to 31 March 2021. The primary endpoint is the rate of vascular complications (major and minor) pre and post-TAVI procedure. In total, 264 patients were included. There were no significant differences in vascular complications (major and minor) between the two groups (13.6% in the MANTA group versus 21.2% in the PROSTAR group; p = 0.105), although there was a tendency to have fewer minor vascular complications in the Manta group (12.1% versus 20.5%; p = 0.067). Manta was associated with a lower rate of bleeding complications (3.8% versus 15.2%; p = 0.002), predominantly minor complications with fewer closure failures (4.5% versus 13.6%; p = 0.01), less use of covered stents (4.5% versus 12.9%; p = 0.016), and with no difference in the need for vascular surgery compared to the Prostar group (1.5% versus 2.3%; p = 0.652). On the other hand, Manta was associated with a higher rate of femoral stenosis (4.5% versus 0%; p = 0.013) without clinical significance (1.5% versus 0%; p = 0.156). The Manta and Prostar devices are equivalent in terms of vascular complications. The Manta, compared to the Prostar, is associated with fewer bleeding complications.

Safety and performance evaluation of the automated helical suturing system as compared with the manual suturing platform in endoscopic sleeve gastroplasty in a porcine model

Safety and performance evaluation of the automated helical suturing system as compared with the manual suturing platform in endoscopic sleeve gastroplasty in a porcine model