Device Attachment Research Articles

Comparative analysis of MitraClip/TriClip and PASCAL in transcatheter tricuspid valve repair for tricuspid regurgitation: a systematic review and meta-analysis

BackgroundThe edge-to-edge transcatheter tricuspid valve repair (TTVR) has emerged as a promising technique for the treatment of tricuspid regurgitation (TR). Despite its potential, comparative data on the performance of the novel edge-to-edge devices—MitraClip, PASCAL, and TriClip—remain controversial. In this study, we aim to evaluate the safety and efficacy of these devices in treating TR.MethodsFive databases were systematically searched up to May 2023, with an updated search conducted in May 2024. Only original studies were included in the analysis and were critically evaluated using an adapted version of the Newcastle-Ottawa Scale (NOS) for observational cohort studies and the Cochrane Risk of Bias (ROB) tool for randomized controlled trials.ResultsThe database search yielded 2239 studies, out of which 21 studies were included in the final analysis. These studies encompassed a total of 2178 patients who underwent TTVR using either the MitraClip, TriClip, or PASCAL devices. The risk of bias across these studies ranged from moderate to high. No significant differences were found among the three devices in terms of effective regurgitant orifice area (EROA) and tricuspid regurgitant volume. However, TriClip demonstrated statistically superior efficacy in reducing vena contracta compared to both MitraClip and PASCAL (P < 0.01) [TriClip: (MD = -7.4; 95% CI: -9.24, -5.56), MitraClip: (MD = -4.04; 95% CI: -5.03, -3.05), and PASCAL: (MD = -6.56; 95% CI: -7.76, -5.35)]. The procedural success rates and incidence of single leaflet device attachment (SLDA) were similar across all devices. Furthermore, there were no significant differences in mortality, stroke rates, or major bleeding events among the three devices.ConclusionThe TriClip outperforms the MitraClip and PASCAL in reducing vena contracta width, indicating greater effectiveness for severe tricuspid regurgitation. All devices show similar safety profiles and procedural success rates. Further research is needed to confirm these results.

Ultra-short-term stress measurement using RGB camera-based remote photoplethysmography with reduced effects of Individual differences in heart rate.

Stress is linked to health problems, increasing the need for immediate monitoring. Traditional methods like electrocardiograms or contact photoplethysmography require device attachment, causing discomfort, and ultra-short-term stress measurement research remains inadequate. This paper proposes a method for ultra-short-term stress monitoring using remote photoplethysmography (rPPG). Previous predictions of ultra-short-term stress have typically used pulse rate variability (PRV) features derived from time-segmented heart rate data. However, PRV varies at the same stress levels depending on heart rates, necessitating a new method to account for these differences. This study addressed this by segmenting rPPG data based on normal-to-normal intervals (NNIs), converted from peak-to-peak intervals, to predict ultra-short-term stress indices. We used NNI counts corresponding to average durations of 10, 20, and 30s (13, 26, and 39 NNIs) to extract PRV features, predicting the Baevsky stress index through regressors. The Extra Trees Regressor achieved R2 scores of 0.6699 for 13 NNIs, 0.8751 for 26 NNIs, and 0.9358 for 39 NNIs, surpassing the time-segmented approach, which yielded 0.4162, 0.6528, and 0.7943 for 10, 20, and 30-s intervals, respectively. These findings demonstrate that using NNI counts for ultra-short-term stress prediction improves accuracy by accounting for individual bio-signal variations.

Findings from transoesophageal echocardiographic follow-up after mitral transcatheter edge-to-edge repair.

Transoesophageal echocardiography (TOE) provides accurate evaluation of mitral valve (MV) function following mitral transcatheter edge-to-edge repair (M-TEER) and may better detect complications in case of suboptimal result. We aimed to evaluate midterm anatomical changes and structural complications after M-TEER using TOE and investigate their association with clinical outcomes at 2 years. A follow-up TOE at 6 months was systematically recommended to all patients included in our institutional prospective M-TEER registry until December 2021. We assessed changes in the incidence of mitral regurgitation (MR), MV stenosis (≥5 mmHg), and partial or complete single leaflet device attachment (SLDA) between the index procedure and follow-up and evaluated MV area and annular dimensions in a subset of patients with available three-dimensional (3D) datasets. The clinical endpoint was a composite of mortality and heart failure (HF) rehospitalisation at 2 years. Among the 373 patients included in the registry between February 2012 and December 2021, 128 patients (34%) underwent elective TOE at 6 months. Using TOE, severe MR was observed in 13.3% (n=17) of the patients. The number of patients with an elevated MV gradient increased from 17 (13.3%) after the procedure to 23 (18%) at 6 months, and a new partial or complete SLDA was detected in 7.8% (n=10). Based on 3D TOE measurements, significant increases in MV area, annular area, annular perimeter, and intercommissural (but not anteroposterior) diameter were observed compared to intraprocedural images. A mean MV gradient ≥5 mmHg (hazard ratio [HR] 2.30, 95% confidence interval [CI]: 1.10-4.81; p=0.023) and the presence of severe MR at 6 months (HR 3.26, 95% CI: 1.18-8.99; p=0.023) were associated with the primary endpoint, which was met in 34 (26.6%) patients at 2 years. TOE follow-up allowed the detection of complications that would not be diagnosed using transthoracic echocardiography only and should therefore be used liberally in the patients presenting with a suboptimal result. A mean MV gradient ≥5 mmHg and severe MR, diagnosed at the 6-month TOE follow-up, were associated with adverse clinical outcomes.

A Study on the Catch Losses and Mesh Selectivity Related to the Attachment of Marine Mammal Bycatch Reduction Devices on Midwater Trawl Gear

The National Institute of Fisheries Science in Korea is developing marine mammal bycatch reduction devices (BRDs) for high-risk fishing gear, such as trawls. We experimented with two BRD types (guiding nets) attached in front of codend at 30° and 45° angles, and catch losses and mesh size selectivity were investigated. Experimental fishing operations were conducted along the East Coast of South Korea where whales and dolphins are commonly sighted. The catch was classified according to fishing location, BRD type, codend, and covernet, with measurements recorded for body length, maximum girth, and weight. The average selectivity for each haul was analyzed using the ‘selfisher’ package. The catch loss rates with the BRD attached at tilt angles of 30° and 45° were 11% and 29% for common flying squid, 6% and 28% for sailfin sandfish, and 5% and 8% for pearlside. While the mesh selectivity rates for common flying squid and pearlside remained at 0.2–0.5 across all lengths and tilt angles, the mesh selectivity curve for sailfin sandfish was estimated. There were significant differences in catch loss between 30° and 45° angles, with the 30° angle being more effective in catch loss. We observed a masking effect in the codend.

Long‐term effects of tagging fishes with electronic tracking devices

AbstractTagging fishes with internal or external electronic tracking devices (acoustic, radio, satellite, or archival tags) is invaluable to behavioural, ecological, and welfare research, but may have adverse effects on the animals studied. While short‐term responses to tagging (e.g., days to weeks) have often been investigated, less information is available on longer‐term impacts (e.g., months to years) and the potential chronic effects of tagging on basic biological needs such as foraging and reproduction. Here, we synthesize existing knowledge from peer‐reviewed acoustic, radio, satellite, and archival tagging articles (n = 149) and anecdotal accounts (n = 72) from 36 researchers to assess the effects of tagging over prolonged periods. We identified a dearth of research that has specifically measured or quantified the impacts of tagging over a period longer than a few weeks or months (e.g., median experimental study duration = 33 days; n = 120 articles). Nevertheless, there was limited evidence to support a net negative long‐term impact from the implantation or attachment of electronic devices. Considerations and future research directions are discussed with the goal of generating guidance to the research community and minimizing potentially detrimental impacts to study animals. Given the global application and relevance of electronic tagging research to inform conservation and management of fishes, it is imperative for scientists to continue evaluating how tagging procedures affect animal welfare, fate, and the interpretation of tracking data.

A Pressure-Sensitive, Repositionable Bioadhesive for Instant, Atraumatic Surgical Application on Internal Organs.

Pressure-sensitive adhesives are widely utilized due to their instant and reversible adhesion to various dry substrates. Though offering intuitive and robust attachment of medical devices on skin, currently available clinical pressure-sensitive adhesives do not attach to internal organs, mainly due to the presence of interfacial water on the tissue surface that acts as a barrier to adhesion. In this work, a pressure-sensitive, repositionable bioadhesive (PSB) that adheres to internal organs by synergistically combining the characteristic viscoelastic properties of pressure-sensitive adhesives and the interfacial behavior of hydrogel bioadhesives, is introduced. Composed of a viscoelastic copolymer, the PSB absorbs interfacial water to enable instant adhesion on wet internal organs, such as the heart and lungs, and removal after use without causing any tissue damage. The PSB's capabilities in diverse on-demand surgical and analytical scenarios including tissue stabilization of soft organs and the integration of bioelectronic devices in rat and porcine models, are demonstrated.

The Role of 24-Hour Holter Electrocardiogram in the Early Detection of Atrial Fibrillation in Newly Diagnosed Acute Ischemic Stroke Patients.

Introduction Stroke is a leading cause of death and disability globally, with atrial fibrillation (AF) recognized as a significant risk factor due to its association with increased stroke recurrence and mortality. Timely detection of AF is crucial to prevent recurrent strokes and improve outcomes. This study primarily aimed to evaluate the utility of 24-hour Holter monitoring for AF detection in acute ischemic stroke patients. Methods This retrospective observational study examined data from 207 patients admitted with acute ischemic stroke to a tertiary-care hospital over a two-year period. Patients with pre-existing AF, transient ischemic attacks, unconfirmed diagnoses, and missing Holter reports were excluded. A total of 140 patients were included in the analysis. The study investigated AF detection rates, the relationship between AF and stroke risk factors, other Holter findings, and the time delay in attaching Holter monitors. Results Of the 140 patients evaluated, AF was detected in nine (6.4%), exclusively in those aged ≥65 years. The most prevalent risk factors among the study participants were hypertension (74.3%) and diabetes (61.4%). No significant correlations were observed between AF and the analyzed stroke risk factors. The median delay for Holter device attachment was 3,503 minutes (approximately two days and 10 hours), with longer delays noted in males (4,084 mins (approximately two days and 20 hours) vs. 2,565 mins (approximately one day and 18 hours), p=0.005). Premature atrial complexes(PACs) were notably associated with the absence of AF, suggesting their potential role as markers for undiagnosed AF. Conclusion The study highlights the limited utility of 24-hour Holter monitoring in detecting AF in acute ischemic stroke patients, advocating for extended monitoring durations, especially in older patients. To improve AF detection, potential strategies include using longer monitoring periods and optimizing hospital workflows to reduce delays in attaching Holter devices. These approaches can minimize the risk of underdiagnosing paroxysmal AF, thereby preventing recurrent strokes and improving patient outcomes. Further investigation into PACs as potential predictive markers for AF is warranted.

Indications and outcomes of the MitraClip G4 device with controlled gripper actuation system.

The MitraClip G4 device has controlled gripper actuation (CGA) system, which allows the anterior and posterior grippers operate separately in transcatheter edge-to-edge repair (TEER). We investigated the indications and outcomes of the use of CGA system during TEER for significant mitral regurgitation (MR). We reviewed 158 patients undergoing TEER with MitraClip G4 from September 2020 to July 2023. The CGA indications were: (1) for grasping and (2) for leaflet insertion confirmation. Leaflet grasping was completed with CGA in 18 patients (11 and 7 patients for grasping and leaflet insertion confirmation, respectively). Patients with flail leaflets or coaptation gap more frequently required CGA, indicating more complex mitral valve anatomy. The procedural success and adverse event rates (death, leaflet tear and single leaflet device attachment) were not different between the CGA and non-CGA groups. In patients requiring CGA, single leaflet device attachment was observed in 1 patient and leaflet tear in 1 patient during follow-up. In these two cases, CGA was required for grasping, and the clip was moved over a large distance (6.5 and 12.4mm, respectively). In patients who had undergone CGA for confirmation, no device-related adverse event or MR recurrence was noted. In patients with complex mitral valve anatomy, CGA may be a safe and effective method for confirming leaflet insertion. It should be noted that when using CGA for leaflet grasping, especially when the clip is moved significantly, attention should be paid to leaflet adverse events.

A meta-analysis of parrot tracking studies reveals the difficulties of transmitter attachment to Little Corella (Cacatua sanguinea)

ABSTRACT Little Corellas (Cacatua sanguinea) are notorious for damaging crops and ornamental trees, and are an overabundant nuisance native in some urban areas. Habitat and landscape use studies ideally require the attachment of tracking devices. Here, we describe an attempt to attach GPS transmitters to Little Corellas using the backpack and keel-strap harness method. All five tracking devices initially attached to Little Corellas were removed by the birds within 48-hours. Additionally, a conspecific was observed chewing on the Teflon ribbon of a GPS harness shortly after the release of a Little Corella; a novel record that suggests cooperative abilities for the species. To complement our study, we conducted a literature review of parrot (psittacine) tracking studies. We investigated attachment styles and potential reasons for past device removals. Of the 46-relevant studies, neck collars were the most common attachment method (38.8%), followed by backpack harnesses (24.5%). Transmitter removal was documented in 28.3% of studies, with removals being most common for medium-sized (500–1000 g) species, and for combination (simultaneous back- and tail-mounts; n = 4) and backpack harness attachments (n = 6). Although there are relatively few parrot telemetry studies to date, they are increasing, and future studies will require considerable innovation and collaboration to overcome attachment style hurdles for difficult species, like the Little Corella.

Development and evaluation of a modular smart garment framework

PurposeThis study aims to develop and evaluate a modular smart garment design framework that simplifies the technical content associated with smart garment design.Design/methodology/approachSmart garment design challenges were first identified through literature review and interviews. Then, a modular framework and toolkit was created to address these challenges. Finally, workshops were held to evaluate the modular toolkit.FindingsInterviews highlighted the need for easier attachment of hard devices to soft textile materials, simpler electrical connection creation and straightforward device selection. A modular framework was proposed and divided into four elements: (1) the Central Computation Module, (2) Peripheral Electrical Modules, (3) Securely Attaching Modules with Substrates and (4) Managing Intra-garment Connections. Workshops showed the modular framework had statistically significant improvements in function and certain ease ratings when compared to non-modular components.Originality/valueThis research identified specific technical challenges faced by smart garment designers and alleviated them through a modular smart garment framework that in workshops outperformed non-modular components in key function and ease ratings.

Mechanical Effects of Medical Device Attachment to Human Tympanic Membrane.

Several treatment methods for hearing disorders rely on attaching medical devices to the tympanic membrane. This study aims to systematically analyze the effects of the material and geometrical properties and location of the medical devices attached to the tympanic membrane on middle-ear vibrations. A finite-element model of the human middle ear was employed to simulate the effects of attachment of medical devices. Various types of material and geometrical properties, locations, and modeling scenarios were investigated for the medical device. The attachment of the device magnifies the effects of anti-resonances of the middle ear. Additionally, the variations of the material properties of the device significantly alter the middle-ear resonance frequency while changes in the umbo and stapes footplate motions are negligible at frequencies above 5kHz. Furthermore, modeling the device as a point mass cannot accurately represent the implanted middle-ear behavior. The variations of the diameter and height of the medical device have negligible effects on the middle-ear vibrations at frequencies below 200Hz but can have considerable impacts at higher frequencies. The effects of changing the device height were negligible at frequencies above 2kHz. We also discuss the effects of medical device attachment on the vibration patterns of the tympanic membrane as well as the impacts of the variations of the location of the device on the stapes footplate responses. The findings of our study aid the development and optimization of new therapeutic devices, attached to the tympanic membrane, to have the least adverse effects on middle-ear vibrations.

Comparison study of intraoperative surface acquisition methods on registration accuracy for soft-tissue surgical navigation.

To study the difference between rigid registration and nonrigid registration using two forms of digitization (contact and noncontact) in human in vivo liver surgery. A Conoprobe device attachment and sterilization process was developed to enable prospective noncontact intraoperative acquisition of organ surface data in the operating room (OR). The noncontact Conoprobe digitization method was compared against stylus-based acquisition in the context of image-to-physical registration for image-guided surgical navigation. Data from patients undergoing liver resection were analyzed under an Institutional Review Board-approved study at Memorial Sloan Kettering Cancer Center. Organ surface coverage of each surface acquisition method was compared. Registration accuracies resulting from the acquisition techniques were compared for (1)rigid registration method (RRM), (2)model-based nonrigid registration method (NRM) using surface data only, and (3)NRM with one subsurface feature (vena cava) from tracked intraoperative ultrasound (NRM-VC). Novel vessel centerline and tumor targets were segmented and compared to their registered preoperative counterparts for accuracy validation. Surface data coverage collected by stylus and Conoprobe were and , respectively. The average difference between stylus data and Conoprobe data using NRM was and using NRM-VC was , indicating the registrations to Conoprobe data performed worse than to stylus data with both NRM approaches. However, using the stylus and Conoprobe acquisition methods led to significant improvement of NRM-VC over RRM by average differences of 4.48 and 3.66mm, respectively. The first use of a sterile-field amenable Conoprobe surface acquisition strategy in the OR is reported for open liver surgery. Under clinical conditions, the nonrigid registration significantly outperformed standard-of-care rigid registration, and acquisition by contact-based stylus and noncontact-based Conoprobe produced similar registration results. The accuracy benefits of noncontact surface acquisition with a Conoprobe are likely obscured by inferior data coverage and intrinsic noise within acquisition systems.

Computed tomography anatomic predictors of outcomes in patients undergoing tricuspid transcatheter edge-to-edge repair

AimTo identify anatomical computed tomography (CT) predictors of procedural and clinical outcomes in patients undergoing tricuspid transcatheter edge-to-edge repair (T-TEER). Methods and resultsConsecutive patients undergoing T-TEER between March 2018 to December 2022 who had cardiac CT prior to the procedure were included. CT scans were automatically analyzed using a dedicated software that employs deep learning techniques to provide precise anatomical measurements and volumetric calculations. Technical success was defined as successful placement of at least one implant in the planned anatomic location without single leaflet device attachment. Procedural success was defined as tricuspid regurgitation reduction to moderate or less. Procedural complexity was assessed by measuring the fluoroscopy time. The clinical endpoint was a composite of death, heart failure hospitalization, or tricuspid re-intervention throughout two years. A total of 33 patients (63.6% male) were included. Procedural success was achieved in 22 patients (66.7%). Shorter end-systolic (ES) height between the inferior vena cava (IVC) and tricuspid annulus (TA) (r ​= ​- 0.398, p ​= ​0.044) and longer ES RV length (r ​= ​0.551, p ​= ​0.006) correlated with higher procedural complexity. ES RV length was independently associated with lower technical(adjusted Odds ratio [OR] 0.812 [95% CI 0.665–0.991], p ​= ​0.040) and procedural success (adjusted OR 0.766, CI [0.591–0.992], p ​= ​0.043). Patients with ES right ventricular (RV) length of >77.4 ​mm had a four-fold increased risk of experiencing the composite clinical endpoint compared to patients with ES RV length ≤77.4 ​mm (HR ​= ​3.964 [95% CI, 1.018–15.434]; p ​= ​0,034]). ConclusionCT-derived RV length and IVC-to-TA height may be helpful to identify patients at increased risk for procedural complexity and adverse outcomes when undergoing T-TEER. CT provides valuable information for preprocedural decision-making and device selection.

Innovative non-contact r-r intervals estimation using viterbi algorithm with Squared Branch Metric (VSBM)

Non-contact heartbeat detection by using Doppler sensor is a critical component of remote health monitoring systems, enabling continuous and unobtrusive monitoring of an individual’s cardiovascular health. In this paper, we reported an innovative approach for non-contact heartbeat detection using the Viterbi algorithm, leveraging the distribution of the difference of two adjacent R-R intervals (RRIs). RRIs represent the time between successive peaks in the electrocardiogram (ECG) signal and are fundamental in analyzing heart rate variability, mental stress conditions and heart diseases. Numerous non-contact Doppler sensor-based methods have been proposed for heartbeat detection, leveraging the evaluation of RRIs without physical device attachment. However, challenges arise from unwanted peaks introduced by respiration and slight body movements, even when the subject remains motionless with normal breathing. This study presented an innovative approach for selecting heartbeat peaks utilizing the Viterbi algorithm with the squared difference of two adjacent RRIs as the Branch metric (BM). Our preliminary experiments reveal that the difference between two adjacent RRIs closely follows a Gaussian distribution. Building upon this observation, we considered the Viterbi algorithm with Squared Branch Metric (VSBM) to estimate the heartbeat accurately. To assess the accuracy of our peak selection method, we conducted experiments comparing it with two existing peak detection methods: (i) Doppler output after Low-Pass Filter (LPF)-based method and (ii) Spectrogram-based method. Our results demonstrate that the proposed VSBM method is effective to detect the heartbeat accurately for each peak detection method. Furthermore, we compared the performance of “Spectrogram + VSBM” outperforms the “Doppler output after LPF + VSBM” method by the Root-Mean-Square Error (RMSE) of RRIs.

User requirements for non-invasive and minimally invasive glucose self-monitoring devices in low-income and middle-income countries: a qualitative study in Kyrgyzstan, Mali, Peru and Tanzania

AimsDevelopment of non-invasive and minimally invasive glucose monitoring devices (NI-MI-GMDs) generally takes place in high-income countries (HICs), with HIC’s attributes guiding product characteristics. However, people living with diabetes (PLWD) in...

범죄예방을 위한 전자감시제도의 실태와 문제점에 관한 고찰

Electronic monitoring systems are being used as an alternative to incarceration for the prevention of crime and reduction of correctional costs in many countries. Additionally, electronic monitoring is understood to contribute to the rehabilitation of criminals. The electronic monitoring system is significant as a new criminal sanction suitable for the characteristics of crimes. However, there is controversy related to the double jeopardy and the ex post facto law. Issues also arise regarding the infringement of the monitored individual's rights to freedom and privacy, and whether it is a cost-effective criminal sanction in terms of crime prevention effectiveness and reduction in recidivism rates.&#x0D; In this context, many countries are expanding the scope of electronic monitoring as one of the criminal sanctions. The Korean ‘Law on Attachment of Electronic Devices’ is also continuously expanding the range of crimes subject to electronic monitoring. However, there are problems in the legal aspects of the electronic monitoring system and in terms of criminal policy. Given the lack of empirical research on recidivism reduction, crime prevention effectiveness, and cost-benefit analysis, it seems prudent to be cautious in expanding the application of the electronic monitoring system.&#x0D; The expansion of the electronic monitoring system could lead to a broader social surveillance network. The system, rather than being an alternative to incarceration, could function as a new form of ‘digital incarceration’. Therefore, the electronic monitoring system requires limited operation. Additionally, the focus should not only be on the machines and equipment but also on expanding and training the operational staff. The primary goals of electronic monitoring, such as crime prevention and reduction in recidivism, cannot be achieved solely through mechanical electronic surveillance. A combination of various supplementary rehabilitation programs and trained human resources is necessary for the operation of these systems.

Feasibility of a Percutaneous and Non-Fluoroscopic Procedure for Transcatheter Mitral Valve Edge-to-Edge Repair.

Transcatheter edge-to-edge repair (TEER) of the mitral valve has emerged as an alternative treatment for mitral regurgitation (MR). However, the high radiation exposure during the process has been associated with multiple adverse effects for medical staff. In this study, we assessed the feasibility and safety of TEER performed solely under the echocardiographic (echo) guidance. Between April 2021 to August 2021, we retrospectively collected characteristics of 23 patients with MR who underwent TEER under echocardiographic guidance exclusively. Follow-up evaluations were performed at 1- , 3-months and 1-year post procedure. All 23 patients (mean age, 66.1 12.1 years; 65.2% males) successfully underwent echo-guided TEER, with 22 patients under transesophageal echo (TEE) guidance and 1 patient under transthoracic echo (TTE) guidance for severe esophageal stenosis. Of the patients, 60.9% received 1 implant and 39.1% received 2 implants. The median total procedural time was 130 (interquartile range, IQR: 90-150) min and the device procedure time was 73 (IQR: 58-100) min. The median length of stay was 6 (IQR: 5-9) days. At 3-months follow-up, 63.6% of patients had an MR 1+ and 90.9% had an MR 2+ (p 0.001 vs. baseline). Improvement in functional status was observed, with 40.9% of patients classified as New York Heart Association (NYHA) functional class I and 45.5% as NYHA functional class II (p 0.001 compared to baseline) at 3-months. At 1-year follow-up, 90.4% maintained MR reduction with MR 2+ (p 0.001 vs. baseline). Single leaflet device attachment (SLDA) occurred in one patient (4.3%) 1-week post procedure. This retrospective, single-center, and pilot study demonstrates the feasibility, safety, and low complication rates of TEER guided solely by echocardiography. Our findings support the systematic use of echocardiography as the sole guidance modality for TEER, highlighting its potential as an alternative to fluoroscopy-guided procedures. Further multicenter and comparative studies are warranted to confirm these results and provide a more comprehensive evaluation of this approach.

Characterization of Tricuspid Valve Anatomy and Coaptation Gap in Subjects Receiving Tricuspid Transcatheter Edge-To-Edge Repair: Observations From the bRIGHT TriClip Study

Transcatheter edge-to-edge repair (TEER) for the treatment of tricuspid regurgitation (TR) has experienced fast adoption following commercial approval. Defining the appropriate target population for TEER therapy is important to guide patient selection. The aim of this study was to characterize tricuspid valve anatomy and coaptation gap in subjects receiving TEER for the treatment of TR in a contemporary postmarket setting. The bRIGHT study is a prospective, multicenter, single-arm, postmarket study evaluating the safety and effectiveness of the TriClip device. Procedural outcomes included implant success, acute procedural success, TR severity, major adverse events, single-leaflet device attachment, and embolization through 30 postprocedure days. Tricuspid valve characteristics, including morphology, annulus size, and leaflet mobility, were assessed via two-dimensional transesophageal echocardiography from the screening visit by an independent echo core lab to characterize subject variability. Coaptation gap measurements were taken in both the transgastric short-axis (TG SAX) and RV inflow/outflow views. The independent echo core lab performed a detailed assessment of the tricuspid valve on 135 consecutive subjects with available TG SAX views from 24 sites. Tricuspid valve morphologies included 2 to 5 leaflets, with a non-trileaflet valve in 28% of subjects and ≥4 leaflets in 21% of subjects. The etiology of TR was functional in 91% (96/105), mixed in 7% (7/105), and lead induced in 2% (2/105) of subjects. Leaflet mobility was mildly restricted in 69% (78/113) and moderately restricted in 7% (8/113) of subjects. Annulus diameter averaged 4.7±0.7cm with a range of 2.5 to 6.2cm. From the TG SAX view, the coaptation gap measured 8.1±3.1 and 5.2±2.3mm in the central and mid regions of the anterior-septal coaptation line and 6.6±3.2 and 3.8±2.1mm in the central and mid regions of the septal-posterior coaptation line, respectively. From the right ventricular inflow/outflow view, the coaptation gap measured 4.7±2.4, 5.2±2.4, and 4.6±3.0mm in the anterior, mid, and posterior regions of the tricuspid valve, respectively. Thirty-day TR reduction (by number of grades) was similar among subjects with coaptation gaps of <7mm, 7 to 10mm, and >10mm. A broad range of anatomies was observed in this postmarket population. Characterization of the tricuspid valve and coaptation gap will help to better understand and better define the target patient population for tricuspid TEER therapy.

Thirty-day Outcomes of First-in-man Implantation of a Novel Transcatheter Edge-to-edge Mitral Repair System in Patients With Severe Mitral Regurgitation

Objectives: The aim of this multicenter, prospective, single-arm pilot study (ClinicalTrials.gov number: NCT05040074) was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system, SQ-Kyrin®-M Clip (Shenqi Medical, Shanghai, China), in patients with severe mitral regurgitation (MR). Methods: The heart team considered patients from 5 centers in China with clinically significant functional mitral regurgitation ≥3+ despite optimal medical therapy or degenerative mitral regurgitation ≥3+ with high surgical risk as candidates for transcatheter repair. All patients received transcatheter edge-to-edge mitral valve repair under general anesthesia. The primary outcome was technical success, which included all of the following measured at the exit from the catheterization laboratory: (1) absence of procedural mortality; (2) successful access, delivery, and retrieval of the device delivery system; (3) successful deployment and correct positioning of the first intended device; and (4) no emergency surgery or reintervention related to the device or access procedure. The secondary outcomes included all-cause mortality, serious adverse events, device success, and procedural success 30 d after the intervention. Results: From June 2021 to December 2021, 18 patients were enrolled in this study with age (75.7 ± 7.4) years. Fifteen patients had MR 4+, while 3 had MR 3+. Technical success was achieved in all patients, including 6 degenerative mitral regurgitation and 12 functional mitral regurgitation patients. There was no all-cause mortality at 30 d. One patient had single leaflet device attachment within 30 d, which was regarded as a serious adverse event, and the patient was successfully treated with reintervention by implanting another clip. Another patient’s transmitral gradient was 6 mmHg (&gt;5 mmHg), with an effective orifice area of 2.57 cm2 after the procedure. Sixteen patients had device success and procedural success at 30 d postoperation. Fourteen patients had MR 1+, 3 had MR 2+, and only 1 patient had MR 3 + 30 d after the procedure. Conclusions: The results of this feasibility study showed the efficacy and safety of the SQ-Kyrin®-M device in the Chinese population with severe MR, laying a solid foundation for a subsequent large-scale confirmatory study.

1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study

BackgroundThe fourth-generation mitral transcatheter edge-to-edge repair (M-TEER) device introduced an improved clip deployment sequence, independent leaflet grasping, and 2 wider clip sizes to tailor the treatment of patients with mitral regurgitation (MR) for a broad range of anatomies. The 30-day safety and effectiveness of the fourth-generation M-TEER device were previously demonstrated. ObjectivesThe aim of this study was to evaluate 1-year outcomes in a contemporary, real-world cohort of subjects treated with the MitraClip G4 system. MethodsEXPAND G4 is an ongoing prospective, multicenter, international, single-arm study that enrolled subjects with primary and secondary MR. One-year outcomes included MR severity (echocardiographic core laboratory assessed), heart failure hospitalization, all-cause mortality, functional capacity (NYHA functional class), and quality of life (Kansas City Cardiomyopathy Questionnaire). ResultsA total of 1,164 subjects underwent M-TEER from 2020 to 2022. At 1 year, there was a durable reduction in MR to mild or less in 92.6% and to none or trace in 44.2% (P < 0.0001 vs baseline). Few subjects had major adverse events through 1 year (<2% for myocardial infarction, surgical reintervention, or single-leaflet device attachment). The 1-year Kaplan-Meier estimates for all-cause mortality and heart failure hospitalization were 12.3% and 16.9%. Significant improvements in functional capacity (NYHA functional class I or II in 82%; P < 0.0001 vs baseline) and quality of life (18.5-point Kansas City Cardiomyopathy Questionnaire overall summary score improvement; P < 0.0001) were observed. ConclusionsM-TEER with the fourth-generation M-TEER device was safe and effective at 1 year, with durable reductions in MR severity to ≤1+ in more than 90% of patients and concomitant improvements in functional status and quality of life.