Search

In the diagnosis and treatment of brain diseases, implantable devices have immense potential for intracranial sensing of brain activity and application of controlled therapy for providing feedback to the sensing. Flexible materials are preferred for implantable devices, as they can minimise implanted device-brain tissue mechanical mismatch. Moreover, biodegradable implantable devices can reduce potential immunological side-effects. Biodegradability also helps avoid the burdensome secondary surgery for retrieving the implanted device. In this study, we reviewed recent advancements related to the use of flexible and biodegradable type of implantable devices for the diagnosis and treatment of brain diseases. Representative cases of intracranial sensing and feedback therapy are introduced, and then a brief discussion concludes the review.

Open transosseous repair was historically considered the gold-standard surgical solution for rotator cuff tears; however, with advancements in arthroscopic surgery, this procedure was largely replaced by anchor-based techniques. Yet, the ability of anchor-based techniques to achieve similar biomechanical fixation remains uncertain. In this article, we describe a reproducible, economical, arthroscopic anchorless transosseous rotator cuff repair technique that uses an Omega configuration. This technique involves two bone tunnels and four high-strength polyethylene sutures and is suitable for medium-to-large rotator cuff tears that would alternatively need multiple anchors. This procedure not only maximizes the tendon-footprint contact area without using any implanted device but also theoretically lowers the bone laceration rate and is cost effective. In the current Technical Note, the procedure is described in detail along with several tips and tricks. Classifications Level I, shoulder; Level II, rotator cuff., Technique Video Video 1 The arthroscope is first inserted to the joint for simple intra-articular inspection and management. Then, the scope is shifted to the subacromial space to perform bursectomy and acromioplasty before the repair begin. The cuff edge is examined and trimmed to a smooth crescent shape to ease traction suture application and manipulation of the cuff. The tuberosity spur is removed, and decortication is done at the footprint area where we planned to create the bone tunnels. A 1.5-mm straight punch is used to create the anterior pilot hole. Then, a no. 5 Ethibond suture needle is introduced into the pilot hole and slowly inserted further by using a curved needle holder, which is inserted through the lateral portal, and finally piercing the lateral humeral cortex. The scope is then moved to the subdeltoid space to seek the needle tip, which is then retrieved through the lateral portal. The posterior tunnel is created with the same manner. The suture can now be used for shuttling of the cuff sutures. The whole configuration is made from four polyethylene cuff sutures. They are attached to the proximal portion of the torn cuff by tissue penetrator. The inferior limbs are brought to the lateral row through bone tunnels via the shuttle sutures, which were previously placed within the tunnels. The medial row is tightened and tied first at the inferior limb of the anterior cortex, and then the cross-link sutures, and lastly, the traction limbs. Completion of the tying knots results in the final construct of the omega-shaped configuration.

The use of cerebrospinal fluid (CSF) shunts remains a fundamental therapeutic modality in the management of hydrocephalus. Nowadays, neurosurgeons have an arsenal of different shunt technologies on their hands, with several companies producing many different configurations of them. The greatest difficulty of treating a child with hydrocephalus is to deal with a brain that will enormously change its size and hydrodynamic conditions and a body that will multiply its height and weight in a short time. Detailed knowledge of the hydrodynamic properties of shunts is mandatory for any neurosurgeon and much more for those taking care of pediatric patients. It is necessary to know that these properties of the valve may influence the evolution of the patient after shunting and it is recognized that a patient physiology-specific valve selection may yield better outcomes and decrease complications. This article provides a summary of the most common available CSF valves and overdrainage control devices, their technology, and possible combinations. The objective is to offer a quick overview of the armamentarium to facilitate the recognition of the implanted device and improve the selection of the most suitable valve for each patient.

Background Shared decision making and patient-centred communication have become part of pre-procedural decisions and perioperative care across medical specialties. However, gaps exist in patient communication about the implanted device received and the benefits in sharing information about their procedure and device. Objective To understand the patients' knowledge of identifying information for their implanted devices and perspectives on sharing their implanted device information. Methods Four focus groups were conducted with patients who had received a cardiac or vascular implanted device from one of the study sites within the previous 6 months. Data were transcribed and thematically analysed. Results Five themes emerged: lack of awareness of identifying information on implanted devices; value of information on implanted devices; varying trust with sharing device information; perceived risk with sharing device information; and lack of consensus on a systematic process for tracking implanted devices. Discussion Patients desire post-procedural information on their implanted device and a designated plan for longitudinal follow-up, but lack trust and perceive risk with broadly sharing their implanted device information. Conclusion After receiving an implanted device, post-procedural patient communication needs to be expanded to include identifying information on the device including the unique device identifier, how long-term tracking will be supported and the process for notification in case of a problem with the device. This communication should also include education on how sharing device information supports patients' long-term health care, post-market safety surveillance and research. Patient or public contribution The research team included members who were also patients with implanted devices.

Many patients with continuous-flow left ventricular assist devices (CF-LVAD) have other, co-existing implantable cardiac devices. While such devices often function appropriately, there is potential for electromagnetic interference (EMI). A literature review was performed to identify cases of EMI between CF-LVAD and other implanted cardiac devices to better understand their etiology, outcomes, and the strategies used to overcome such interference. The cases identified included interference between CF-LVAD and pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy. The EMI reported in the current literature can be broken down into two general categories: interference leading to difficulty establishing telemetry and interference leading to impaired electrical signal sensing. Such interference led to inappropriate shock delivery in some cases. The type of interference, and thus treatments, differed and were device dependent. The strategies employed to reduce interference included metal shielding, physical manipulation to increase the distance between devices, and even exchange of the implanted device with another brand of the same class. To avoid such EMI in the future, physicians must be aware of the reported interference between certain devices, and manufacturers must work more closely to increase the compatibility of implanted cardiac devices.

Disconnecting a patient from artificial life support, on their request, is often if not always a matter of letting them die, not killing them-and sometimes, permissibly doing so. Stopping a patient's heart on request, by contrast, is a kind of killing, and rarely if ever a permissible one. The difference seems to be that procedures of the first kind remove an unwanted external support for bodily functioning, rather than intervening in the body itself. What should we say, however, about cases at the boundary-procedures involving items that seem bodily in some respects, but not others? When, for instance, does deactivating an implanted device like a pacemaker count as killing, and when as letting die? Contra existing proposals, I argue that the boundaries of the body for this purpose are not drawn at the boundaries of the self, or (if this is different) the human organism. Nor should we determine when we are killing and when we are letting die by deferring to existing practices for distinguishing ongoing from completed treatment. Rather, I argue that whether something (organic or inorganic) counts as body part for purposes of this distinction depends on the results of a normative analysis of the particular character of our rights in it-particularly, whether and in what way these rights ought to be alienable. I conclude by arguing that there are likely good reasons to recognize distinctively "bodily" rights and restrictions in at least some implantable devices.

The aim of this study was to determine the magnitude of the risks associated with cochlear implantation. Results from a pool of thirty clinical studies involving cochlear implantation in over 6300 children were obtained from an internet search. The relevant data were transformed to a common time base (patient time) to allow an evaluation of events following implantation. The main outcome measure was cumulative survival probability for all-cause revision surgery. Over 10 years this was estimated to be 0.71. Thus, at 10 years post-implantation close to 30% of children with unilateral implants will have undergone revision surgery. This figure is considerably greater than that commonly reported for overall revision rates and illustrates the importance of interpreting results with respect to the relevant time frame. When non and low-use is incorporated into the analysis the above figure rises to about 37% of children affected. The findings raise concerns about the information provided to both individuals and regulatory bodies regarding the risks associated with cochlear implantation. The consequences for bilateral implantation are apparent. Our recommendations are i) a full disclosure to parents and children of the true magnitude of the risks and ii) for a body with significant expertise in reliability and systems engineering, and no conflicts of interest, to play a major role in the regulatory management of this service.

Over the past 50 years, incredible progress has been made with implantable devices. Management can become complex, as unique issues arise with interaction of these devices with other devices and technologies. The cochlear implant (CI) is the most commonly implanted device in the head and neck. Because of its internal magnet, CIs can interfere with MRI, causing imaging artifacts, pain, and device complications. Other implants demonstrate similar issues with imaging and co-implantation. This article provides an overview of special considerations regarding neurostimulation devices within the head and neck. We focus on interactions between implantable devices and other technologies or devices.

Objectives To compare the relationship between the third heart sound (S3) measured by implantable cardiac devices (devS3) and auscultation (ausS3) and evaluate their prognostic power for predicting heart failure events (HFEs). Methods In the MultiSENSE study, devS3 was measured daily with continuous values while ausS3 was assessed at study visits with discrete grades. They were compared between patients with and without HFEs at baseline and against each other directly. Cox proportional hazard models were developed between follow-up visits (FUs) and over the whole study. Simulations were performed on devS3 to match limitations of auscultation. Results Nine hundred patients were studied, of whom 106 patients experienced 192 HFEs. Two S3 sensing modalities correlated with each other but at baseline only devS3 differentiated patients with or without HFEs (p Conclusions S3 measured from implantable cardiac devices has stronger prognostic power to predict episodes of future HF events than that of auscultation.

Background: Real-time three-dimensional transesophageal echocardiography (RT3D TEE) enables better visualization of the left atrial appendage (LAA) and may be superior to real-time two-dimensional transesophageal echocardiography (RT2D TEE) for LAA occlusion (LAAO). The aim of this study was to assess inter- and intra-observer variability of RT2D TEE and RT3D TEE measurements of LAA, and to assess the accordance of RT2D TEE and RT3D TEE with appropriate occluder selection. Methods: Transesophageal echocardiography was performed in 40 patients during LAAO. RT2D TEE and RT3D TEE measurements of the ostium and landing zone were performed independently by two echocardiographers. The appropriate choice of occluder was confirmed with fluoroscopic criteria. After the procedures, RT2D TEE and RT3D TEE evaluation were repeated separately by the same echocardiographers. Results: The mean ostium diameters by RT2D TEE obtained by the two observers were 23.6 ± 4.2 vs. 24.8 ± 5.2 (p = 0.04), and the mean landing zone diameters were 17.7 ± 4.4 vs. 19.4 ± 3.9 (p < 0.01). In the case of RT3D TEE, the ostium diameters were 29.6 ± 5.3 vs. 29.4 ± 6.4 (p = not significant [NS]) and the landing zone diameters were 21.4 ± 3.8 vs. 21.6 ± 3.9 (p = NS). Intra-observer differences were absent in the case of RT3D TEE. The comparison of RT2D TEE vs. RT3D TEE analyses performed by the same echocardiographer revealed significant differences in the ostium and landing zone measurements (both p < 0.01). Agreement between the suggested device size was better for RT3D TEE (weighted kappa was 0.62 vs. 0.28, respectively). Conclusions: The results obtained with RT3D TEE showed significantly larger dimensions of the ostium and the landing zone. RT3D TEE showed lesser inter- and intra-observer variability and better agreement with the implanted device.

Coronavirus disease 2019 (COVID-19) has been responsible for an epidemic of devastating proportion, and it has represented a challenge for worldwide healthcare systems with the need of resources reallocation in order to face epidemic spread. Italy was one of the hardest hit countries by COVID-19, and the Italian government adopted strict rules to contain the spread of the COVID-19 pandemic, such as national lockdown and home quarantine; moreover, the Italian healthcare system had to rapidly re-organize the diagnostic and therapeutic pathways, with a reallocation of health resources and hospital beds, in order to manage COVID-19 patients. The aim of the present review is to provide an overview of the effects of the first pandemic wave on cardiovascular assistance in Italy with the purpose of evaluating the strengths and weaknesses of the Italian health system.

Wewnątrznaczyniowe urządzenia wszczepialne w sposób istotny zmniejszają śmiertelność i poprawiają rokowanie w grupie pacjentów z przewlekłądysfunkcją układu sercowo-naczyniowego. Zaliczamy do nich stymulatory serca, kardiowertery-defibrylatory oraz urządzenia resynchronizujące.Stosowanie tych urządzeń postrzegane jest jako bezpieczne oraz klinicznie efektywne. Jednakże w piśmiennictwie pojawiają się opisy jednostkowychprzypadków skórnej reakcji alergicznej lub systemowej reakcji nadwrażliwości w związku z implantowanym urządzeniem. Celem pracy byłaocena częstości występowania powyższych powikłań w procedurach elektroterapii. Do badania włączono 1683 pacjentów poddanych procedurzeimplantacji urządzenia wszczepialnego w latach 2008–2018 na Oddziale Kardiologii Szpitala Wojewódzkiego we Włocławku. W trakcie prowadzonejobserwacji nie zarejestrowano ani jednego przypadku skórnej reakcji alergicznej lub systemowej reakcji nadwrażliwości na wszczepioneurządzenie. W analizowanej populacji w całym okresie obserwacji zarejestrowano 3 przypadki zakwalifikowane do planowej eksplantacji układu.W każdym z nich potwierdzono etiologię infekcyjną jako przyczynę powikłań, izolując patogen z materiału okołooperacyjnego.

Background Telemetry is a wireless implanted device that measures biological signals in conscious animals and usually requires surgery for its removal when the study is finished. After removing the device, the animals are either used for other studies or euthanatized. Case presentation Herein, we report the case of a living cynomolgus monkey (Macaca fascicularis) that was used for the entire experimental period, instead of euthanasia, after surgical removal of an implanted telemetry system. Radiography was used to determine the status of the implanted telemetry, following which, a repair surgery was performed for removing the system; clinical signs were used to preserve the life of the cynomolgus monkey. Postoperative clinical signs, food consumption, hematology, and serum biochemistry were examined during the 12-month observational period. No abnormal readings or conditions were observed in the subject after implant removal. Conclusions This study may be a useful case report for living cynomolgus monkeys in telemetry implantations used throughout the study period. We suggest minimizing the suffering and improving the welfare of these animals.

Electrical stimulation has been used for at least two millennia to treat nervous system disorders. The brain-machine inter face - physical contact between brain tissue and an implanted device - has under gone dramatic refinement over a much shorter period, the past century. Feedback guided electrical stimulation (a key component of cybernetics) is more recent still-less than a quarter century. Examples of major advances in the technology employed in the brain-machine inter face are presented, for both electrical and chemical activity in the brain. A first step towards a “neural prosthesis” or implanted replacement for a principal component of the brain's network architecture - a bioinspired synapse - is described. As noted by Norbert Wiener 75 years ago, technological advancements come with the danger that they may be used for nefarious purposes.

Millions of active implanted devices like pacemakers are implanted every year. Life of those devices depends on the life of battery used for powering. If the battery is drained out then the patient needs to undergo surgery for the second time to replace the device, which potentially increases the risk for other complications and infections. With increase in the demand for implantable devices, researchers are expected to look for extending the life of the device by recharging them wirelessly or by making them self-powered device. This paper gives overall idea about evolution of battery, its specifications to be used in medical device or categorization of batteries, charge pump technology to boost the available charge and factors need to be considered while selecting the battery for any application. With the proper selection of rechargeable battery, if the implanted device is recharged successfully without causing any harm to human body, then the life of the device can be increased as well as its size can be reduced as much of the device space is consumed by the battery.

Recent advances in implanted device development have enabled chronic streaming of neural data to external devices allowing for long timescale, naturalistic recordings. However, characteristic data losses occur during wireless transmission. Estimates for the duration of these losses are typically uncertain reducing signal quality and impeding analyses. To characterize the effect of these losses on recovery of averaged neural signals, we simulated neural time series data for a typical event-related potential (ERP) experiment. We investigated how the signal duration and the degree of timing uncertainty affected the offset of the ERP, its duration in time, its amplitude, and the ability to resolve small differences corresponding to different task conditions. Simulations showed that long timescale signals were generally robust to the effects of packet losses apart from timing offsets while short timescale signals were significantly delocalized and attenuated. These results provide clarity on the types of signals that can be resolved using these datasets and provide clarity on the restrictions imposed by data losses on typical analyses.

Background We sought to evaluate the additional value of left atrial appendage (LAA) 3D printing derived from computed tomography (CCT) in determining the size for LAA occlusion (LAAO) devices as compared to standard measurement by using occurrence of LAA leak as endpoint. Methods We evaluated 6 patients with LAA leak (cases) and 14 matched patients without LAA leak (controls) after LAAO. For each group, a patient-specific 3D printed model of LAA was manufactured using CT pre-operative images. The size recommended by the 3D printed model was compared with the size of the implanted device. Results Compared to the 3D printed model, 55% of the devices were underestimated, the two sizing approaches agreed in 35% of the patients, while the 3D printed model overestimated the size in 10% of patients. The prevalence of LAA leak was significantly higher in the subset of patients with underestimation of prosthesis implanted with the standard approach as compared to the other patients (p = 0.019). Conclusion 3D printing of the LAA may provide additional value to standard practice for LAAO device prosthesis sizing with the potential impact to reduce LAA leak.

Conventional implantable electrocardiogram monitors are impenetrable to electromagnetic radiation, posing challenges in imaging (i.e. X-rays). In this study, we demonstrate a radiolucent implantable electrocardiogram (ECG) device using graphene sheets and Parylene substrate which allows bypassing of electromagnetic radiation through the implanted device. Evaluated on a canine model, the graphene electrodes detect signals comparable to those recorded using surface electrodes, presenting a valuable and novel modality for medium and long-term monitoring of cardiac rhythm. When compared with current technology, the new system has the distinct advantages of being flexible and radiolucent, thereby improving patient comfort, and avoiding device artifact and shadowing on clinical radiographic imaging.

OBJECTIVEFor patients with highly asymmetrical Parkinson’s disease (PD), unilateral subthalamic nucleus (STN) deep brain stimulation (DBS) has been suggested as a reasonable treatment. However, the results of a previous 2-year follow-up study involving patients with prominently asymmetrical PD who had unilateral STN DBS suggested that simultaneous bilateral surgery should be performed. In the present study, the authors analyze 7-year follow-up data from the same patient group to examine changes in motor benefit from unilateral STN DBS over time and the interval between initial unilateral surgery and a second (contralateral) STN DBS surgery.METHODSEight patients with highly asymmetrical parkinsonism who underwent unilateral STN DBS were evaluated. The factors measured were scores on the motor part of the Unified Parkinson’s Disease Rating Scale (UPDRS III), Hoehn and Yahr (HY) stage, and levodopa equivalent daily dose (LEDD). Evaluations occurred at 3, 6, and 12 months after the initial surgery and annually thereafter.RESULTSThe mean follow-up period was 91.5 months (range 36–105 months). Three years after the initial unilateral surgery, motor benefits on the contralateral side continued; however, an aggravation of the ipsilateral parkinsonism attenuated the improvement in total UPDRS III scores, which reverted to baseline. Axial motor score, LEDD, and HY stage did not differ from the baseline. Seven of 8 patients (87.5%) were considered candidates for a second surgery to offer additional motor benefits. Of the 7 candidates, 4 patients (50% of total patients) underwent the second surgery at 58.5 ± 11.6 (mean ± SD) months after the initial surgery. Three patients were not able to have the second surgery: one patient died of gastric cancer, one patient was severely immobilized by an accident, and one patient could not afford the second surgery. One patient remained content with the initial unilateral surgery throughout the follow-up period.CONCLUSIONSSeven of 8 patients with unilateral STN DBS became candidates for second surgery before battery replacement surgery of the first implanted device. Baseline asymmetry alone may not predict appropriate candidates for unilateral STN DBS. This study provides further evidence that, from a long-term perspective, initial simultaneous bilateral STN DBS should be considered for PD patients with prominently asymmetrical motor symptoms.

Heart failure (HF) is a complex chronic illness that affects the older adult population, requiring medical therapy and day-to-day management to prevent worsening and exacerbation. Patients with HF are often treated with cardiac implanted electronic devices (CIEDs) which capture diagnostic and predictive parameters for HF. In this work we explore how patients would respond to receiving data from an implanted device, using a fictitious scenario interview method with 24 older adults with HF. We applied an uncertainty management lens to better understand how patients face uncertain outcomes and integrate novel data into their decision making. The findings provide insight into how patients would engage and respond to a technology which provides an indicator of their HF status from an implanted device.

Highlights Local SVP infection is a common and potentially avoidable complication. Local SVP infection is usually verified by cultures. The transfer rate of pathogens across the SVP membrane may be reduced by applying a positive-pressure flow technique when puncturing the membrane.

Resistive random access memory (RRAM) devices were designed using Al2O3/La2O3/Al2O3 multi-stacked films grown by atomic layer deposition as functional layers. The impact of Al+ ions implantation on the resistive switching performances of the RRAM devices was investigated. Compared with the control sample without Al+ implantation, forming-free operation and larger ON/OFF resistance ratio were achieved in the Al+ implanted RRAM device. Besides, the resistive switching stability and electrical uniformity of the implanted device were enhanced. The enhanced performances of the Al+ implanted RRAM device were deduced by the improvement in the formation and disruption of conducting filaments in the Al2O3/La2O3/Al2O3 multi-stacked films.

IntroductionFatigue is a debilitating symptom of subjective nature which lacks effective therapy. The aim of the study was to assess levels of fatigue and the associated factors among patients with permanent cardiac pacemaker (PCM).Material and methodsThis was a cross-sectional study carried out in Athens. The study sample consisted of 250 patients with a PCM.ResultsData indicated moderate to low levels of fatigue. Furthermore, women (median: 24, p = 0.001), those with primary school education (median: 21, p = 0.001), those who were “a little-not at all” informed about PCM (median: 31, p = 0.001), those who had someone to help them in daily activities (median: 23, p = 0.001), those who did not believe that PCM solved their cardiac problem (median: 36, p = 0.001), and those who did not believe that their quality of life was improved (median: 35, p = 0.001) had high levels of fatigue. Moreover, high levels of fatigue were felt by those who characterized themselves as anxious and those who reported to be very anxious about their heart rate and the proper function of PCM (medians: 21.5, 25 and 25 respectively). Additionally, more fatigue was felt by participants who did not smoke after implantation and did not exercise at all (medians: 20 and 24 respectively). Finally, older patients felt more fatigue (rho = 0.248) while the later the implantation device was inserted the more fatigue the patients felt (rho = 0.274).ConclusionsThe present results will help clinicians to acquire an in-depth knowledge of factors associated with fatigue after implantation.

Background: Deep brain stimulation (DBS) is an established treatment for hyperkinetic movement disorders. Patients undergoing DBS can choose between the use of a rechargeable or non-rechargeable battery for implanted pulse generators (IPG).Objectives: In this study, we aimed to evaluate patient preferences and satisfaction with rechargeable and non-rechargeable batteries for IPGs after undergoing DBS.Methods: Overall, 100 patients with hyperkinetic movement disorders (dystonia: 79, Tourette syndrome: 21) who had undergone DBS took a self-designed questionnaire to assess their satisfaction and experience with the type of battery they had chosen and the factors influencing their choice.Results: Of the participants, 87% were satisfied with the stimulating effects of the treatment as well as the implanted device; 76% had chosen rechargeable devices (r-IPGs), 71.4% of whom recharged the battery themselves. Economic factors were the main reason for choosing both r-IPG and non-rechargeable IPG (nr-IPG). The questionnaire revealed that 66% of the patients checked their r-IPG battery every week. The mean interval for battery recharge was 4.3 days.Conclusions: The majority of the patients were satisfied with their in-service-IPG, regardless of whether it was a r-IPG or nr-IPG. Affordability was the main factor influencing the choice of IPG. The majority of the patients were confident in recharging the battery of their r-IPG themselves; only 11% of patients experienced difficulties. Understanding the recharge process remains difficult for some patients and increasing the number of training sessions for the device may be helpful.

Neurostimulation provides a new dimension in the treatment of neurologic disorders. For patients with drug-resistant epilepsy, the Responsive Neurostimulation (RNS) System (NeuroPace, Inc.) provides treatment of seizures with a closed-loop device that continuously records brain activity and provides stimulation designed to reduce seizure frequency over time. The presence of a chronic implanted device that can provide an electrographic record of neural activity provides great opportunities for treatment of seizure disorders and neuroscience research. However, our experience with this device indicates that a number of ethical and clinical challenges arise, and these issues may be applicable to neurotechnology developed for other disease states in the future. We present clinical scenarios based on cases from our center that present clinical or ethical dilemmas. The dilemmas revolve around 4 core themes: (1) electroclinical correlation and dissociation; (2) patient concerns about device capabilities; (3) clinician opportunities and burdens; and (4) data ownership and access. Developing a framework for understanding these issues will be critical as closed-loop neuromodulation is applied to a growing range of neuropsychiatric disorders.

Background: Procedural success of transcatheter left atrial appendage closure (LAAC) is dependent on correct device selection. Three-dimensional transesophageal echocardiography (3DTEE) is more accurate than the two-dimensional (2D) modality for evaluation of the complex anatomy of LAA. However, 3D-TEE analysis of LAA is challenging and highly expertise dependent. In this study, we sought to evaluate the feasibility and accuracy of a novel software tool for automated 3D analysis of the LAA using 3D-TEE data. Methods: The intra-procedural 3D TEE data of 158 patients who underwent LAAC were retrospectively analyzed with a novel automated LAA analysis software tool. Based on the 3D TEE data, the software semi-automatically segmented the 3D LAA structure, determined the device landing zone (LZ), and generated measurements of the LZ dimensions and the LAA length, allowing manual editing if necessary. The accuracy of LAA pre-implantation anatomic measurement reproducibility, and time for analysis of the automated software were compared against expert manual 3D analysis. The software feasibility to predict the optimal device size was directly compared to implanted models. Results: Automated 3D analysis of the LAA on 3D-TEE was feasible in all patients. There were excellent agreements between automated and manual measurements of LZ maximal diameter (bias:-0.32, LOA:-3.56; 2.92), area-derived mean diameter (bias:-0.24, LOA:-3.12, 2.64), and LAA depth (bias:0.02, LOA:-3.14; 3.18). Automated 3D analysis, with manual editing if necessary, accurately identified the implanted device size in 90.5% of patients, outperforming 2DTEE (68.9%, p, This work was funded by the projects “NORTE-01-0145-FEDER-000045” and “NORTE-01-0145-FEDER-000059”, supported by Northern Portugal Regional Operational Programme (Norte2020), under the Portugal 2020 Partnership Agreement, through the European Regional Development Fund (FEDER). It was also funded by national funds, through the FCT – Fundação para a Ciência e Tecnologia and FCT/MCTES in the scope of the project UIDB/05549/2020 and UIDP/05549/2020 and the grant CEECIND/03064/2018. This work was also funded by the Hong Kong Special Administrative Region Government Health and Medical Research Fund (05160976)