Device-related Adverse Events Research Articles

Multicenter Experience With a Novel Real-Time 3-Dimensional Intracardiac Echocardiography Catheter to Guide Interventional Cardiac Procedures.

Recent technologies enable real-time 3-dimensional intracardiac echocardiography (ICE) with the advantages of 2-dimensional ICE and imaging capabilities of transesophageal echocardiography. The purpose of this study is to evaluate the real-world, multicenter safety and performance of a novel 3-dimensional ICE system in a variety of cardiac interventions used in standard clinical practice. This prospective, multicenter, observational, single-arm study enrolled patients who were scheduled for an invasive cardiac procedure involving guidance with ICE and followed until discharge or ≤48 hours postprocedure. Intracardiac imaging was performed with the 3-dimensional ICE catheter, VeriSight Pro (Philips Inc.). Fluoroscopy was used in all cases and transesophageal echocardiography was used in some cases. The primary safety end point was device-related adverse events. The primary efficacy end point included technical success, imaging success, and clinical success. Between October 2021 and November 2022, 155 patients were enrolled and screened. Percutaneous interventions performed included atrial septal defect/patent foramen ovale closures, left atrial appendage occlusion, catheter ablations, and valve procedures. No adverse events were related to the device or procedure. The technical, imaging, and clinical success rates were 98.7% (95% CI, 95.4%-99.8%), 96.1% (95% CI, 91.8%-98.6%), 94.8% (95% CI, 91.8%-98.6%), respectively. Overall, the VeriSight Pro ICE image quality was assessed to be "acceptable" or greater in relation to reference image modality among 96.2% (149 of 155) of procedures. VeriSight ICE imaging is safe and effective in the guidance of a wide variety of percutaneous cardiovascular procedures and has provided successful and high-quality imaging of cardiac structures.

Vagus Nerve Stimulation Therapy for Treatment-Resistant PTSD.

Vagus Nerve Stimulation Therapy for Treatment-Resistant PTSD.

IBC Oxford University Oral Abstract 42 - Interim results of prospective clinical trial: evaluation of the AEON endoscopic powered stapler handle and reload in primary sleeve gastrectomy

Abstract Background Bariatric surgery is a leading intervention for obesity, with sleeve gastrectomy being the most popular due to its low morbidity and mortality. However, complications like staple line bleeding remain significant. Advanced stapling technologies that enhance safety, ease-of-use, and hemostasis are crucial for next-generation devices. The AEON endoscopic stapler (Lexington Medical, MA, USA) was introduced to the market in 2018 and has been shown to be safe and effective in the approved indications as demonstrated by internal device testing, published animal studies1, 2, and clinical evaluations 3, 4, 5. Lexington Medical has developed a new stapling technology, the AEON Powered Stapling System. The prospective First-in-Man clinical trial was conducted to test the hypothesis that this new technology could enhance consistency and stability during firing, thereby reducing tissue trauma, improving hemostasis, and decreasing postoperative complications. Methods The objective of this prospective, single-arm, single-center study was to evaluate the clinical outcomes of patients undergoing primary sleeve gastrectomy procedures using the AEON Endoscopic Powered Stapler Handle and Reload (Fig. 1). The primary endpoint was to assess the percentage of patients experiencing postoperative staple line complications, namely bleeding or leaks, which required blood transfusion or revision surgery resulting from said complications. In addition, the hemostatic appearance of the staple line was analyzed using a visual analogue score (VAS), graded from 1 to 5 based on bleeding observed at the staple line 10 seconds after completion of resection (Fig. 2). Safety endpoints included evaluating device-related adverse events, serious adverse events, unanticipated adverse device effects, and revision surgeries. Results The study commenced in 2024. We present interim results of 30 consecutive patients who have completed the 3 weeks follow-up in Tables 1, 2. Discussion No intraoperative or postoperative complications were observed during the study. Bleeding Severity Scores were 1.03 + 0.183 on a 1–5 scale indicating that the staple lines were effectively free from bleeding. Figs 3, 4 provide two representative laparoscopic images captured during surgery with the powered handle. Compared to the AEON manual handle where calculated VAS scores in sleeve gastrectomy procedure were found to be 2.1 and 1.5 in published clinical studies 3, 5, the lower powered handle VAS scores support the hypothesis that the AEON Powered Stapling System which adjusts firing speed based on tissue thickness, further improves staple formation and delivers an even more hemostatic staple line than a manual stapler. This hypothesis should be validated with a larger sample size and two-arm powered prospective study. Conclusions The First-in-Man clinical study of the AEON Power Stapling System has demonstrated the device’s safety and effectiveness in performing primary sleeve gastrectomy procedures. The clinical results were notably excellent, particularly in relation to intraoperative and postoperative staple-line bleeding. It is hypothesized that the stapler’s intelligent functionality, specifically its ability to detect tissue thickness and automatically adjust firing speed to facilitate precise dissection, played a significant role in minimizing tissue trauma and contributed to the superior haemostasis, enhancing the overall surgical outcomes

The efficacy, safety and clinical feasibility of a percutaneous atrial septal shunt device for pulmonary arterial hypertension: a single-center cohort study

AimTo evaluate the safety and efficacy of FreeFlow percutaneous atrial septal shunt device (manufactured by AOLIU Medical Technology Co., Ltd, Shanghai, China) in patients with refractory pulmonary arterial hypertension (PAH) for the first time.MethodsThe study enrolled adult patients diagnosed with refractory pulmonary arterial hypertension (PAH) at the Department of Cardiology, Zhongshan Hospital, Fudan University, between Oct 2021 and Oct 2023. The patients were treated with the FreeFlow percutaneous atrial septal shunt device and underwent follow-up immediately after operation, as well as before and after discharge (at 1, 3, 6, 12 months post-operation). The primary endpoints of the study included the rate of major cardiovascular and cerebrovascular adverse events (MACCEs), serious adverse events (SAEs), and serious device-related adverse events (SADEs) within 12 months of shunt implantation. Data analysis was conducted using SAS 9.3.ResultsA total of 12 patients were enrolled in the study and successfully completed the operation. 10 subjects had completed 12 months’ follow-up after operation, while two subjects had died. The incidence of MACCE was 0%, and the incidence of SAEs was 33%, which was unrelated to the treatment with this device. No systemic or instrumental embolizations occurred during the follow-up period. All ten subjects exhibited a stable right-to-left shunt after the operation (100% success rate). Seven patients’ New York Heart Association (NYHA) functional classification improved from grade III to grade II. The Short Form-36 (SF-36) score and the 6-minute walking distance (6MWD) at 12 months post-operation were significantly improved compared to baseline, with scores of 47.6 ± 19.5 versus 64.7 ± 24.6 (P = 0.029) and distances of 239.5 ± 137.8 m versus 401.7 ± 129.6 m (P = 0.045), respectively. Similarly, the levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) and right heart diameter (RAD) also decreased significantly, from 3236 ± 1590.3 pg/mL to 1787.3 ± 703.7 pg/mL (P = 0.039) and from 59.1 ± 10.6 mm to 46.3 ± 7.5 mm (P = 0.046), respectively.ConclusionsThe results of this clinical study demonstrate that the product can attain the anticipated performance under typical conditions of use. The risks associated with the product are deemed acceptable when weighed against its potential benefits. All preclinical and clinical evaluations have furnished definitive and rational scientific evidence supporting the safety and efficacy of the percutaneous atrial septal shunt.Clinical trial numberNot applicable.

Leadless Pacemaker Implantation in an Adolescent with Durable LVAD Support.

Left ventricular assist device (LVAD) utilization is increasing in pediatrics. These patients are often complex and may require treatment of AV block. Leadless pacing has been associated with a lower risk of device-related adverse events, but there are no reports of a leadless pacemaker implant in a pediatric patient with LVAD support. This report describes the use of a leadless pacemaker implantation in a 17-year-old patient with dilated cardiomyopathy and continuous flow LVAD support which facilitated transition to outpatient care.

Ocular Sticks for Routine Ophthalmic Surgery: A Randomized Controlled Monocentric Trial.

Ocular sticks are used to absorb fluids during ophthalmic surgeries. Hence, this prospective study was conducted to evaluate the clinical performance, safety, and usability of Pro-optha® Ocular Sticks in comparison to an alternative device under the conditions of routine ophthalmic surgeries. Patients requiring eye surgery were randomly allocated into two equal groups, with the investigational device, Pro-ophta® Ocular Sticks, as the intervention group (IG) and the alternative stick as the comparator group (CG). Two types of surgery were performed. The study is also registered on the German Clinical Trials Register with ID DRKS00025690. 106 patients were included in the analyses. In both treatment groups, the investigator's/surgeon's general user satisfaction was rated as either "good" or "very good." The non-inferiority hypothesis that the Pro-ophta® Ocular Stick is not rated worse in satisfaction than the alternative device was confirmed with statistical significance (p = 0.0005). At least 98.12% were rated as "good" and "very good" in both treatment groups for the additional endpoints. Pro-ophta® Ocular Stick was rated better for almost all the additional endpoints and within the surgery subgroups. The mean number of sticks and surgery duration were 3.5 ± 2.74 and 11.5 (± 8.88) min, respectively, with a positive correlation (r = 0.580) for the Pro-ophta® Ocular Stick and 3.9 ± 2.45 and 9.5 (± 5.90) min, respectively, with a positive correlation (r = 0.025) for the alternative device. No device-related adverse events occurred. Effective ocular sticks play an instrumental role in the outcome of ophthalmic surgeries. The investigational device demonstrated efficiency, yielding good surgical results, usability, and an exceptionally good safety profile.

Prospective evaluation to characterize the real-world performance of the EMBOVAC aspiration catheter for neurothrombectomy: a post-market clinical follow-up trial

BackgroundA direct aspiration first pass technique (ADAPT) is an effective alternative to stent retriever thrombectomy for patients with large vessel occlusion (LVO). The PERFECT study evaluated direct aspiration with the...

Efficacy and safety of a novel oral hydrogel capsule in adults with overweight or obesity: the pivotal randomized RESET study.

The objective of this study was to investigate the efficacy and safety of the Epitomee capsule versus placebo as an adjunct to high-intensity lifestyle intervention in participants with overweight or obesity. The Randomized Evaluation of Efficacy and Safety of the Epitomee Capsule Trial (RESET) was a prospective, double-blind, placebo-controlled pivotal trial in adults with baseline BMI of 27.0 to 40.0 kg/m2. The co-primary endpoints at week 24 were percentage change from baseline in body weight for the Epitomee and placebo groups and proportion of Epitomee-treated patients achieving ≥5% weight loss compared with a 35% threshold. The primary safety endpoint was the incidence of device-related serious adverse events. A total of 138 participants received Epitomee and 141 received placebo. Mean (SD) change in body weight from baseline was -6.6% (6.5%) with Epitomee and -4.6% ( 4.7%) with placebo; least-squares means were -6.1% (0.6%) and -4.2% (0.6%), respectively (p = 0.0054). Fifty-six percent of Epitomee-treated participants attained ≥5% weight loss from baseline, which was significantly greater than the 35% predefined threshold (p < 0.0001). Twenty-seven percent of Epitomee-treated and eleven percent of placebo-treated participants achieved ≥10% weight loss. Adverse event rates were similar between the groups. No device-related serious adverse events occurred. The Epitomee capsule is a safe and efficacious nonpharmacological option for weight management with potential broad application in participants with overweight or obesity.

Balloon eustachian tuboplasty in chronic suppurative otitis media and dilatory eustachian tube dysfunction: a randomized controlled trial.

Balloon eustachian tuboplasty (BET) is an emerging treatment for dilatory eustachian tube (ET) dysfunction. However, its efficacy in patients with both chronic suppurative otitis media (COM) and ET dysfunction remains unclear. The objective of the trial was to assess the efficacy and safety of BET versus medical management (MM) alone in adult patients with COM and chronic dilatory ET dysfunction, which was defined by a failed Valsalva maneuver. In this prospective, multicenter, randomized controlled trial, a total of 116 participants (121 ears) treated between January 2021 and June 2023 were randomly assigned (1:1) to receive either BET with MM or MM alone (fluticasone furoate nasal steroid spray). The short-term primary outcome was the normalization of the Valsalva maneuver at the 8-week follow-up. Secondary outcomes were improved Eustachian Tube Dysfunction Questionnaire- 7 (ETDQ-7) scores and decreased air-bone gap (ABG) analyzed at 8 weeks. Adverse events were monitored in both groups during the follow-up period. Among the 116 participants (121 ears), 60 participants (62 ears) received BET and 56 participants (59 ears) received MM alone. Demographics, baseline characteristics, ETDQ-7 scores, bone conduction thresholds, and ABG did not differ significantly between the groups. In the BET group, 46.8% (29/62, ears) achieved a successful Valsalva maneuver compared with 15.3% (9/59, ears) in the MM-only group (p<0.001). BET group (-6.2±9.4) showed greater subjective symptom improvement than the MM-only group (-2.6±8.6) regarding ETDQ-7 scores (p=0.028). ABG decreased more in the BET group (-5.8±11.4 dB) compared with the MM-only group (-1.2±10.5 dB) (p=0.023). No serious procedure-related or device-related adverse events occurred in either group during the 8-week follow-up. Our trial suggests that BET, combined with MM, demonstrated superiority over MM alone, along with its safety, in treating dilatory ET dysfunction in patients with COM.

Wearable, noninvasive, pulsed shortwave (radiofrequency) therapy for postoperative analgesia: A randomized, double-masked, sham-controlled pilot study.

Nonthermal, pulsed shortwave (radiofrequency) therapy (PSWT) is a nonpharmacologic, noninvasive modality that limited evidence suggests provides analgesia. Its potential favorable risk-benefit ratio stems from its lack of side effects and significant medical risks, applicability to any anatomic location, long treatment duration, and ease of application by simply affixing it with tape. Even with a relatively small treatment effect, PSWT might contribute to a multimodal analgesic regimen, similar to acetaminophen. However, widespread clinical use is hindered by a lack of systematic evidence. The current randomized, controlled pilot study was undertaken to determine the feasibility and optimize the protocol for a subsequent definitive investigation and estimate the treatment effect of PSWT on postoperative pain and opioid consumption. Within the recovery room following primary knee and hip arthroplasty, cholecystectomy, hernia repair, and non-mastectomy breast surgery, we applied 1-3 PSWT devices (Model 088, BioElectronics Corporation, Frederick, Maryland) over the surgical bandages. Participants were randomized to 28 days of either active or sham treatment in a double-masked fashion. The outcomes of primary interest were the cumulative opioid consumption and the mean of the "average" and "worst" daily pain measured with the Numeric Rating Scale over the first 7 postoperative days. During the first 7 postoperative days, oxycodone consumption in participants given active treatment (n = 55) was a mean (SD) of 21 mg (24) versus 17 mg (26) in patients given sham (n = 57): difference 4 (95% CI, -5 to 13), p = 0.376. During this same period, the "average" daily pain intensity in patients given active treatment was 2.4 (1.6) versus 2.6 (1.7) in sham: difference -0.2 (95% CI -0.8 to 0.5), p = 0.597. Concurrently, the worst/maximum pain for the active group was 4.6 (2.0) versus 4.7 (2.1) in sham: difference -0.1 (95% CI -0.8 to 0.7), p = 0.888. No device-related systemic side effects or serious adverse events were identified. Pulsed shortwave (radiofrequency) therapy did not reduce pain scores and opioid requirements to a statistically significant or clinically relevant degree during the initial postoperative week in this pilot study. These results must be replicated with a subsequent study before being considered definitive. Data from this preliminary study may be used to help plan future trials.

Development and regulatory approval of a new systemic targeted therapy for advanced hepatocellular carcinoma.

613 Background: There are no commercially available devices for the treatment of patients with advanced hepatocellular carcinoma who have failed 1st line and 2nd line therapy. We have identified tumor-specific modulation frequencies in patients with advanced hepatocellular carcinoma. We exposed patients to radiofrequency electromagnetic fields, which are amplitude-modulated from 0.1 Hz to 100 kHz and measured changes in pulse pressure. Frequencies eliciting measurable changes in pulse pressure were selected as tumor-specific frequencies. Methods: Treatment is administered to patients with advanced hepatocellular carcinoma by means of a battery-operated portable device emitting 27 MHz radiofrequency electromagnetic fields, which are amplitude-modulated at hepatocellular carcinoma frequencies. The device is connected to a coaxial cable ending with a spoon-shaped antenna placed on the anterior part of the patient's tongue during treatment. Treatment is administered three times a day for one hour. Results: A total of 69 patients with advanced hepatocellular carcinoma received treatment with the TheraBionic device until progression or death. The median overall survival of patients who received treatment with the TheraBionic device after failing 1st line and 2nd line therapy was 9.15 (95% CI 1.6-34.8) months and the median overall survival of Child-Pugh A patients was 9.5 months, which are comparatively longer than the 7.8 months pooled estimated medians of the placebo arms of 11 randomized 1st line and 2nd line placebo-controlled studies assessing the safety and efficacy of new agents for the treatment of Child-Pugh A advanced HCC (Llovet, Montal et al., J Hepatol 2019). We also analyzed the survival of patients who had received two lines of systemic therapy and did not receive any additional cancer treatment while and after receiving treatment with the TheraBionic device. The median OS of these patients was 9.8 months and the median OS of the Child-Pugh A patients was 17.2 months, which are comparatively longer than the 7.74 months pooled estimated medians of the placebo arms of the above cited 11 randomized studies. To assess unknown device-related adverse events, we assessed patient reported symptoms using the same scale in the SHARP and Asian Pacific Sorafenib studies. The incidence of any grade adverse events among Child-Pugh A who received treatment with the TheraBionic device was not different from the Placebo group of the SHARP and Asian Pacific Sorafenib studies. There were no NCI Grade 2, 3 or 4 toxicities. One patient developed grade 1 mucositis and one patient developed grade 1 fatigue. Conclusions: The data presented here provide reasonable assurance of safety and probable benefit in patients with advanced hepatocellular carcinoma who have failed 1st line and 2nd line therapy: https://www.fda.gov/medical-devices/recently-approved-devices/therabionic-p1-h220001 .

Intracardiac or transesophageal echocardiography for left atrial appendage occlusion? an updated systematic review and meta-analysis

Abstract Background Percutaneous left atrial appendage occlusion (LAAO) is typically performed under the guidance of transesophageal echocardiography (TEE) and fluoroscopy. Intracardiac echocardiography (ICE) appears to be a potential alternative to guide implantation. Purpose We sought to perform a meta-analysis comparing ICE vs TEE for the guidance of percutaneous LAAO. Methods A comprehensive literature search was performed using MEDLINE, Scopus and Web of Science electronic databases from their inception to November 2023 regarding published abstracts and manuscripts. Studies reporting clinical outcomes comparing ICE vs TEE for percutaneous LAAO were included. Primary efficacy and safety outcomes included technical success and the occurrence of any reported procedure-related and device-related complication. Secondary outcomes included procedural characteristics such as procedural time, fluoroscopy time and the volume of contrast agent used. Results A total of 18 studies with 124,230 patients fulfilled the criteria. Outcomes assessed including procedure time between ICE vs TEE (risk ratio [RR], 1.01; 95% CI, 1.00-1.01), fluoroscopy time (MD: 1.45 minutes, 95% CI -1.32 to 4.22, p=0.30) and contrast medium volume (SMD: 0.02, 95% CI -0.23 to 0.26, p=0.89) were found to be similar between both groups. Technical success with higher odds was found with the use of ICE (OR: 1.36, 95% CI 1.14 to 1.63, p=0.006) and fewer devices employed in cases of ICE guidance (SMD: -0.22, 95% CI -0.43 to -0.01, p=0.04, I2=62%). There was also no significant difference in procedure- or device-related adverse events between both groups. Interestingly, patients undergoing LAAO under ICE guidance had higher risk for pericardial effusion/tamponade and iatrogenic residual shunts compared to those in the TEE group (11 studies, RR: 1.66, 95% CI 1.13 to 2.43, p=0.014) and (4 studies, RR: 1.53, 95% CI 1.12 to 2.09, p=0.02, I2=1%), respectively. More vascular complications were noted in cases of ICE (RR: 1.56, 95% CI 1.06 to 2.32, p=0.03). Conclusions Although TEE is the gold standard for perioperative guidance of LAAO, imaging with ICE is an effective alternative to TEE in LAAO procedures. However, further studies are needed to clarify safety of this new perioperative imaging technique.

Rationale and Design of the InsightPFA Trial: A Prospective, Multicenter, Randomized Controlled Trial of the Irreversible Electroporation-Based Pulsed Field Ablation Versus Radiofrequency Ablation in Chinese Patients With Symptomatic Paroxysmal Atrial Fibrillation.

Pulsed field ablation (PFA) is gaining recognition as a nonthermal, tissue-specific technique for the treatment of atrial fibrillation (AF). The preclinical evaluation of the investigated novel PFA system from Insight Medtech Co. Ltd has demonstrated feasibility, safety, and 30-day efficacy for pulmonary vein isolation (PVI) in the swine model. We are currently conducting a randomized controlled trial to compare the PFA directly with ablation-index (AI)-guided radiofrequency ablation (RFA) for PVI. The InsightPFA trial is a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of PFA versus RFA for PVI in Chinese patients with symptomatic paroxysmal AF. Two hundred and ninety-two patients diagnosed with symptomatic paroxysmal AF will be randomly assigned to either the PFA group or the RFA group in a 1:1 ratio. All subjects will undergo PVI using PFA or AI-guided RFA and be followed up to 12 months. The primary endpoint is defined as freedom from any episodes of AF/AFL/AT without Class I or III antiarrhythmic drugs during the 9-month follow-up period after a 90-day blank period. The secondary endpoints of effectiveness include acute treatment success and procedural data. The safety evaluation includes a composite of death, stroke and transient ischemic attack, procedure-related complications, device-related adverse events, and serious adverse events. A noninferiority comparison will be conducted between the novel PFA system and the existing RFA system in terms of both effectiveness and safety. This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF. https://www. gov/study/NCT06014996; NCT06014996.

P0165 A highly miniaturized ingestible sensor for measuring gut health along the GI tract

Abstract Background The human gastrointestinal (GI) tract is challenging to examine due to its intricate structure and inaccessibility. Current diagnostic methods are either invasive, like endoscopy, or offer a limited view, such as faecal tests. Endoscopy capsules allow for a visual inspection of the whole GI tract but still require uncomfortable bowel preparation, including laxatives and dietary restrictions, and cannot provide biochemical analysis of the gut environment. Methods To enable non-invasive assessment of in vivo gut health, we developed a highly miniaturized, ultra-low-power ingestible sensor (the Gastrointestinal Smart Module, or GISMO) capable of measuring pH, temperature, and redox balance throughout the GI tract. Redox balance is crucial for maintaining intestinal barrier function and regulating interactions among the host, immune system, and gut microbiota. Imbalances in redox levels can lead to oxidative stress, characterized by an imbalance between oxidants and antioxidants, and are associated with adverse gut processes, such as inflammation1. Redox balance plays as such an important role in inflammatory bowel disease (IBD)2. The GISMO sensor was validated in both in vitro and in vivo pre-clinical models and subsequently tested in a first-in-human trial. Results In the first-in-human trial, the GISMO system demonstrated feasibility, safety, and ease of use, with 66 ingestible sensors administered to 15 healthy participants. Participants reported ease in swallowing the sensors and expressed willingness to ingest multiple capsules. No device-related adverse events occurred throughout the study. GISMO is the first device capable of measuring in vivo redox balance, providing high-resolution data every 20 seconds. The data revealed consistent profiles from an oxidative environment in the stomach to a strongly reducing environment in the colon. Conclusion We successfully developed, validated, and clinically tested miniaturized technology for assessing GI health in a simple, non-invasive manner. Our ingestible sensors are the first to measure in vivo redox balance along the human gut, requiring no uncomfortable bowel preparation, and enabling real-time monitoring. This innovative technology has the potential to enable easy localization and objective quantification of inflammation, revolutionizing the diagnosis and monitoring of IBD and other gastrointestinal diseases.

Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery: interim analysis of the International Safe and Timely Antithrombotic Removal (STAR) registry

ObjectivePatients on direct-acting oral anticoagulants (DOACs) are at high risk of perioperative bleeding complications. Intraoperative hemoadsorption is a novel strategy to reduce perioperative bleeding in patients on DOACs undergoing non-deferable cardiac surgery. The international STAR-registry reports real-world clinical outcomes associated with this application.MethodsThe hemoadsorption device was incorporated into the cardiopulmonary bypass (CPB) circuit and active for the duration of the pump run. Patients on DOACs undergoing CABG and/or single valve surgery before completing the recommended washout were included. Outcome measurements included bleeding events according to standardized definitions and 24-hour chest-tube-drainage (CTD).ResultsA total of 62 patients were included from 7 institutions in Austria, Germany, Sweden, and the UK (mean age 69.9 ± 7.5years, 71% male). Approximately half were on apixaban and the other half was split between rivaroxaban and edoxaban with 21% of patients also on aspirin. Surgery occurred at a median time of 28.9 h since the last DOAC dose with single valve surgery accounting for 2/3 of cases. Mean CPB duration was 118.6 ± 46.4 min. Severe bleeding (UDPB ≥ 3) occurred in 4.8%, and BARC-4 bleeding occurred in 3.2% of the patients. Only one patient (1.6%) required reoperation for bleeding control. The mean 24-hour CTD was 771.3 ± 482.79mL. No device-related adverse events were reported.ConclusionsThis interim report of the ongoing STAR-registry shows that, in patients on DOAC undergoing non-deferable CABG and/or single valve surgery, the use of intraoperative hemoadsorption is associated with low rates of severe perioperative bleeding complications. Further prospective studies in larger cohorts are needed to validate the efficacy of this method.Clinical registration numberClinicalTrials.gov identifier: NCT05077124.

4.5-Year Follow-up with a Novel Corneal Endothelial Prosthesis.

Refractory corneal edema is the foremost reason for endothelial corneal transplantation (EK) in the world. Descemet membrane endothelial keratoplasty (DMEK) and Descemet stripping automated endothelial keratoplasty (DSAEK) offer good clinical outcomes. However, human donor tissue is limited in availability and has a complex logistical chain. Many patients in need do not have access to EK. Success of the human donor tissue depends on its quality, the number of rebubbles, repeat keratoplasties, and patient-related risk factors. The use of an endothelial corneal keratoprosthesis could benefit patients with a high risk for graft failure and human graft rejection, and patients in underserved areas where tissue banking is unavailable. Case cohort series of 10 eyes of 10 patients implanted with the EndoArt, with a follow-up of up to 4.5 years. Outcome measures are device adherence, central corneal thickness, visual acuity, and incidence of adverse events. In the first seven eyes, the EndoArt was implanted in eyes with low visual potential within the first-in-human (FIH) trial, and in the three remaining eyes, implantation was performed because of either guarded posterior or anterior segment prognosis or the patient's wishes. In 9/10 eyes, device adherence was obtained and maintained throughout the follow-up period. Mean corneal thickness decreased from 927 + SD 241 microns to 621 + SD 140 microns. In 6/10 eyes, visual acuity improved from a mean preoperative value of logMAR 1.94 + 0.63 to a mean postoperative value of logMAR 0.8 + 0.64. No pathological thinning or corneal metabolic changes were seen. The surgical technique was developed during the follow-up period. The EndoArt provided a stable decrease in central corneal thickness, improved vision in 60% of eyes, and had no device-related adverse events. The EndoArt is an additional treatment modality for special cases like repeat corneal graft failure in the population of the Western world, or as a primary procedure in underserved areas worldwide.

Accuracy and feasibility of continuous glucose monitoring system in pancreatectomy patients.

Pancreatectomy patients often experience challenging fluctuations in blood glucose levels; therefore, they require a reliable monitoring system. This study aimed to determine the accuracy and acceptability of a continuous glucose monitoring (CGM) system compared with the intermittent capillary glucose test in patients who have undergone pancreatectomy. Thirty non-diabetic pancreatectomy patients participated. We used the FreeStyle Libre Flash Glucose Monitoring System (Abbott Diabetes Care) for continuous interstitial glucose monitoring. Capillary reference glucose levels were checked four times daily. Accuracy was checked using the Clarke Error Grid. The mean age of the participants was 56.8 ± 12.0 years, of whom 61.3% underwent pancreaticoduodenectomy and 38.7% underwent distal pancreatectomy. Three patients developed pancreatogenic diabetes after pancreatectomy. The clinical accuracy of continuous glucose monitoring compared with capillary glucose was 43.9% in Zone A (clinically accurate zone) and 99.8% in Zone A + B (low risk of error) of the Clarke Error Grid. No device-related adverse events were reported. Patients rated favorable user acceptability on the questionnaire. This pilot study demonstrated that the CGM device is accurate and safe for patients who underwent pancreatectomy, with favorable user acceptability. Despite these challenges, the study proposes that the CGM device is beneficial for monitoring glucose levels after discharge in patients with impaired glucose levels following pancreatectomy.

Focused Ultrasound Neuromodulation: Exploring a Novel Treatment for Severe Opioid Use Disorder.

Focused Ultrasound Neuromodulation: Exploring a Novel Treatment for Severe Opioid Use Disorder.

Enhanced Endothelialization Using Resveratrol-Loaded Polylactic Acid-Coated Left Atrial Appendage Occluders in a Canine Model.

Left atrial appendage occlusion (LAAO) is a well-established alternative to anticoagulation therapy for patients with atrial fibrillation who have a high bleeding risk. After occluder implantation, anticoagulation therapy is still required for at least 45 days until complete LAAO is achieved by neoendocardial coverage of the device. We applied a polylactic acid-resveratrol coating to the LAAO membrane to enhance endothelialization with the goal of shortening the anticoagulation therapy duration. Eighteen dogs were randomly divided into the experimental group (coated occluders) or the control group (noncoated occluders). The dogs were sacrificed in cohorts at days 14, 28, and 90 for anatomical and pathological examination to evaluate endothelialization and thrombus formation. Transesophageal echocardiography (TEE) was performed before sacrifice to evaluate device-related adverse events. According to the anatomical and pathological examinations, all except one LAAO cover exhibited larger or thicker tissue or neoendocardial coverage in the experimental group compared with the control group at the same sacrifice time points. All connection hubs were densely covered by endothelial cells at 90 days and completely covered at 28 days in the experimental group, while all connection hubs were thinly covered at 90 days and two connection hubs were exposed at 28 days in the control group. Pathological examination revealed no thrombus formation in the experimental group, while a small amount of thrombus was observed in one dog at 90 days and in two dogs at 28 days in the control group. Finally, TEE showed no peri-device leakage (PDL) in the experimental group, whereas a small amount of PDL was detected in one dog (3.2 mm) at 28 days and in one dog (3.7 mm) at 14 days in the control group. The resveratrol-loaded polylactic acid-covered LAAO device enhanced endothelialization and reduced thrombus formation and PDL. This effect could possibly reduce the anticoagulation therapy duration.

The Effects of Alfapump on Ascites Control and Quality of Life in Patients With Cirrhosis and Recurrent or Refractory Ascites.

The Effects of Alfapump on Ascites Control and Quality of Life in Patients With Cirrhosis and Recurrent or Refractory Ascites.