Successfully Implanted Research Articles

First-in-Man Study of a Novel, Balloon-Adjustable Mitral Annuloplasty Ring.

Objectives: Mitral valve repair is the current standard approach for mitral valve regurgitation. However, patients suffering from functional mitral regurgitation have a significant risk of recurrent regurgitation. Adjustable mitral rings may provide a solution for this adverse event. Methods: A single-center, first-in-man clinical study was performed on patients suffering from mitral valve regurgitation. Patients were implanted with the study ring and followed for six months. A balloon catheter can be inserted into the study ring frame at any time after implantation and inflated independently in the areas P1, P2, or P3, which reduces the anterior-posterior diameter. Results: Five patients (75.4 ± 6.1 years; EuroSCORE II 2.1 ± 0.9%; three female) were successfully implanted. Mechanisms of mitral regurgitation were prolapse of the P2-segment in three patients and annular dilation in two patients. Surgical implantation according to the protocol was feasible and is described herein. Median cardiopulmonary bypass time and cross clamp time were 105 (118; 195) and 94 (90; 151) min, respectively. The median intensive care unit stay was 2 (2; 3) days. No perioperative, 30-day, or 6-month mortality was observed, and the repair was stable without residual or recurrent regurgitation ≥ grade 2. All patients reached the primary endpoint without device-related morbidity. Conclusions: Successful implantation was completed in five patients without device-related adverse events. Ring implantation was safe and feasible for all patients. The opportunity of post-implant adjustment to improve leaflet coaptation is a promising new therapeutic strategy that is assessed in a phase II study.

Case Report: The combined effect of endometrial receptivity array and laser assisted hatching on embryo implantation in repeated implantation failure case

This case report describes a couple with nine years of primary infertility and three failed in vitro fertilization (IVF) attempts that showed no reproductive abnormality. Negative results were observed following the conventional IVF protocol. The couple then insisted on laser-assisted hatching (LAH) and endometrial receptivity analysis (ERA). The ERA results showed a specific window for embryo implantation, and accordingly, the treatment was carried out, which resulted in seven good-quality oocytes, leading to the formation of four blastocyst-stage embryos. These embryos were then frozen, single embryo transfer (ET) was performed following the ERA results, and the embryos were successfully implanted. The βhCG level was 245 mIU/mL, indicating that the female had successfully conceived. This case highlights the challenges of a thick zona pellucida and recurrent implantation failure (RIF), defining how a personalized method combining both LAH and ERA could lead to successful implantation.

Post-shock acute electrical parameters of left bundle branch area defibrillation (LBBAD) leads

Abstract Funding Acknowledgements Type of funding sources: None. Background Conduction system pacing is a growing field in bradycardia-treatment. Evidence for His bundle pacing (HBP) and left bundle branch area pacing (LBBAP) to prevent pacing induced cardiomyopathy is growing. Promising data is also emerging to use CSP as an additional tool in cardiac-resynchronisation therapy (CRT). (1-5). Very often patients requiring an ICD also have an indication for bradycardia or resynchronisation pacing. Adding CSP-treatment to these patients requires an additional pacing lead (HBP or LBBAP) and the use of a CRT-D device. As opposed to HBP, in LBBAP atrial oversensing cannot occur. Using an ICD-lead in this position could reduce the number of intracardiac leads needed while maintaining the possibility of sensing and treating ventricular arrhythmias. Purpose We evaluated the acute electrical parameters before and after delivering an ICD shock with an ICD-lead positioned in the left bundle branch area (LBBA). As this ICD-lead position has never been described before, no data is available on dislocation after shock-delivery. We looked at the electrical parameters of the successful LBBAP ICD-lead implants in our LBBAD (Left Bundle Branch Area Defibrillator) pilot-trial which is a proof-of-concept study for LBBA-ICD lead implantation. Methods In the LBBAD pilot trial, we implant an ICD lead in the LBBA to evaluate for feasibility of implantation and functionality of defibrillation. As this is a proof of concept trial, after testing the lead is re-implanted in a conventional ventricular position. In this abstract we report the evaluation of the electrical parameters of the first 3 successfully implanted LBBAD-leads (n=3). Results After LBBA implantation initial electrical parameters were measured. The pacing threshold was 0,8 +/- 0,6 V @ 0,4 ms, while the sensed R-wave and the impedance measured 7,0 +/- 2,7 mV and 512,3 +/- 38,8 Ohms respectively. The shock-coil impedance was 68,0 +/- 7,0 Ohms. All these parameters are in range with the parameters seen in conventional ICD-lead implantation. After performing the defibrillation threshold test (DFT) all electrical parameters were re-evaluated. Sensing, threshold and impedance were 7,6 +/- 2,2 mV, 0,8 +/- 0,7 V @ 0,4 ms, 516,3 +/- 47,8 Ohms and 71,7 +/- 8,2 Ohms respectively. These post-shock measurements remained stable within normal ICD-lead functioning range precluding acute dislocation. Conclusions Our LBBAD pilot trial is the first-in-human experience with ICD-leads implanted in the LBBA. This pilot trial evaluates for implant-feasibility and also looked at the pre- and post shock electrical parameters of the ICD-lead. As the parameters remained in normal working range, precluding acute shock-induced dislocation, these results open the possibility in patients with an LBBAP-indication as well as an ICD-indication, for a follow-up study to implant an LBBAD-lead and perform longer-term evaluation.

Transcatheter Leadless Pacing in Children: A PACES Collaborative Study in the Real-World Setting.

Transcatheter Leadless Pacemakers (TLP) are a safe and effective option for adults with pacing indications. These devices may be an alternative in pediatric patients and patients with congenital heart disease for whom repeated sternotomies, thoracotomies, or transvenous systems are unfavorable. However, exemption of children from clinical trials has created uncertainty over the indications, efficacy, and safety of TLP in the pediatric population. The objectives of this study are to evaluate clinical indications, procedural characteristics, electrical performance, and outcomes of TLP implantation in children. Retrospective data were collected from patients enrolled in the Pediatric and Congenital Electrophysiology Society TLP registry involving 15 centers. Patients ≤21 years of age who underwent Micra (Medtronic Inc, Minneapolis, MN) TLP implantation and had follow-up of ≥1 week were included in the study. The device was successfully implanted in 62 of 63 registry patients (98%) at a mean age of 15±4.1 years and included 20 (32%) patients with congenital heart disease. The mean body weight at TLP implantation was 55±19 kg and included 8 patients ≤8 years of age and ≤30 kg in weight. TLP was implanted by femoral (n=55, 87%) and internal jugular (n=8, 12.6%) venous approaches. During a mean follow-up period of 9.5±5.3 months, there were 10 (16%) complications including one cardiac perforation/pericardial effusion, one nonocclusive femoral venous thrombus, and one retrieval and replacement of TLP due to high thresholds. There were no deaths, TLP infections, or device embolizations. Electrical parameters, including capture thresholds, R wave sensing, and pacing impedances, remained stable. Initial results from the Pediatric and Congenital Electrophysiology Society TLP registry demonstrated a high level of successful Micra device implants via femoral and internal venous jugular approaches with stable electrical parameters and infrequent major complications. Long-term prospective data are needed to confirm the reproducibility of these initial findings.

254 DIFFERENT DEGREES OF DEGENERATION OF TRANSCATHETER VALVES IMPLANTED IN THE AORTIC POSITION OR EMBOLIZED DISTALLY: A CASE REPORT

Abstract While transcatheter aortic valve replacement (TAVR) gradually emerges as first line therapy for aortic disease in most surgical risk groups, structural prosthetic degeneration remains an issue that may must be considered when planning procedures in younger patients. We present the case of a 74 years old female who underwent a valve-in-valve TAVR following degeneration of a previously implanted TAVR which had initially been complicated by distal embolization of two prosthetic valves. The patient initially underwent TAVR in 2010 for severe aortic regurgitation and a porcelain aorta. The procedure was complicated by distal embolization of two prosthetic valves; firstly a 26 mm Sapien valve migrated to the pre-renal abdominal aorta. This was followed by the embolization of a 29 mm CoreValve to the descending thoracic aorta. Finally, on the third attempt, a 29 mm CoreValve was successfully implanted without complication. The patient remained clinically stable until February 2022 when she developed progressively worsening effort angina and dyspnea. Echocardiographic evaluation demonstrated prosthetic aortic valve degeneration with cusp fibrosis and calcification, with severe aortic regurgitation. Interestingly, neither of the embolized prosthetic valves showed signs of deterioration on CT imaging. The valve that had migrated to the abdominal aorta did not show any significant increase in gradient or regurgitation on Doppler evaluation. After careful evaluation and Heart Team discussion, a transfemoral valve-in-valve (ViV) procedure was performed uneventfully with a 23 mm Sapien Ultra implant, that resulted in complete abolition of regurgitation with mild prosthesis-patient mismatch (mean gradient 15 mmHg, EOA 0.8 cm2/m2). Post-procedural CT imaging confirmed a satisfactory result with no signs of dislocation of the previous valve prostheses (Figure 3). The patient was safely discharged on day 4 post-op on oral anticoagulation (due to a history of atrial fibrillation), and was asymptomatic at 30-day follow-up. This case report describes a challenging but successful ViV TAVR implantation.

Combining Machine Learning with Metabolomic and Embryologic Data Improves Embryo Implantation Prediction

This study investigated whether combining metabolomic and embryologic data with machine learning (ML) models improve the prediction of embryo implantation potential. In this prospective cohort study, infertile couples (n=56) undergoing day-5 single blastocyst transfer between February 2019 and August 2021 were included. After day-5 single blastocyst transfer, spent culture medium (SCM) was subjected to metabolite analysis using nuclear magnetic resonance (NMR) spectroscopy. Derived metabolite levels and embryologic parameters between successfully implanted and failed groups were incorporated into ML models to explore their predictive potential regarding embryo implantation. The SCM of blastocysts that resulted in successful embryo implantation had significantly lower pyruvate (p<0.05) and threonine (p<0.05) levels compared to medium control but not compared to SCM related to embryos that failed to implant. Notably, the prediction accuracy increased when classical ML algorithms were combined with metabolomic and embryologic data. Specifically, the custom artificial neural network (ANN) model with regularized parameters for metabolomic data provided 100% accuracy, indicating the efficiency in predicting implantation potential. Hence, combining ML models (specifically, custom ANN) with metabolomic and embryologic data improves the prediction of embryo implantation potential. The approach could potentially be used to derive clinical benefits for patients in real-time.

Endosaccular flow disruption with the Contour Neurovascular System: angiographic and clinical results in a single-center study of 60 unruptured intracranial aneurysms

BackgroundThe Contour Neurovascular System is a novel device designed to treat intracranial aneurysms by intrasaccular flow disruption. We report our experience and mid-term follow-up in a series of patients treated...

Preclinical safety and electrical performance of novel atrial leadless pacemaker with dual-helix fixation.

Complications associated with transvenous pacemakers, specifically those involving the lead or subcutaneous pocket, may be avoided with leadless pacemakers (LPs). The safety and efficacy of single-chamber right ventricular LPs have been demonstrated, but their right atrium (RA) use poses new design constraints. The purpose of this study was to evaluate the implant success, electrical performance, and safety of a novel RA LP design in benchtop and preclinical studies. A new LP was designed with a dual-helix fixation mechanism specific to the RA anatomy. A 12-week preclinical ovine study was conducted to evaluate implant success, electrical performance, mechanical stability, and safety invivo, with supporting benchtop measurements to quantify the mechanical forces needed for device retrieval and dislodgment. LPs were successfully implanted in all 10 ovine subjects with no complications. The pacing capture threshold improved significantly over time from implant to week 12 (1.1 ± 0.7 V vs 0.4 ± 0.2 V, P = .008). Sensing amplitudes and pacing impedances were stable from implant to week 12 (4.8 ± 1.8 mV vs 6.0 ± 1.9 mV, P = .160; and 393 ± 77 Ω vs 398 ± 65 Ω, P = .922, respectively). Gross pathology and microscopic histology revealed no adverse interactions and no evidence of device dislodgment or clinically significant myocardial perforation. Benchtop exvivo porcine atrial tissue measurements revealed greater pull forces required to dislodge the LP vs transvenous active fixation lead (0.42 ± 0.18 lbf vs 0.29 ± 0.08 lbf, P = .020), and greater rotational forces required for deliberate extraction (0.28 ± 0.04 lbf vs 0.14 ± 0.07 lbf, P <.001). The novel atrial LP demonstrated successful implantation, with acceptable electrical performance, mechanical stability, and safety in a 12-week preclinical study.

Penile Prosthesis in Transgender Men after Phalloplasty.

A penile prosthesis can be successfully implanted after phalloplasty in transgender men to permit sexual intercourse. A prosthesis can be categorized as malleable or inflatable. The most common penile prosthesis implanted after masculinizing genital surgery is the inflatable prosthesis but this can be a challenging operation with high complication rates. Penile prosthesis in transgender patients differs from cis-patients in many respects but one critical difference is the absence of the tough, protective tunica of the corporal body to contain the prosthesis. This causes greater mobility of the prosthesis under the skin and increases the risk of migration and erosion of the device through the skin. In addition, to overcome the absence of a corpora cavernosa, the proximal portion of the prosthesis must be anchored to bone. Complications include injury to the urethra, vascular injury, skin breakdown, infection, device migration, device failure, extrusion, and erosion. There is no robust data on the use of penile prosthesis in transgender men with only multiple reports of small numbers of patients. While successful implantation can improve patients' quality of life, surgeons should counsel patients about the relatively high risk of the need for revision surgery.

The Clinical Efficacy of Haploidentical Hematopoietic Stem Cell Transplantation by Using Parental Donors in Patients with Thalassemia

To analyze the clinical efficacy of haploidentical hematopoietic stem cell transplantation (haplo-HSCT) by using parental donors on thalassemia patients. The 13 thalassemia patients treated by haplo-HSCT using parental donors in our hospital from July 1, 2016, to July 1, 2020 were retrospectively reviewed. Hematopoiesis reconstitution, the incidence of GVHD, infections and the long-term survival of the patients were analyzed. Twelve of the 13 patients were successfully implanted, the success rate of implantation was 92.3%. The median time of neutrophil and platelet engraftment was 12.5 days (range, 9-22 days) and 21 days (range,12-34 days), respectively. One patient achieved primary graft failure. Three (25%) patients developed to acute GVHD (aGVHD) and achieved complete remission after treatment. Chronic GVHD developed in three (25%) patients, one of them was extensive and under treatment, while one patient developed to severe bacterial infection (7.7%). CMV viremia was diagnosed in two patients (15.4%). There were no patients developed to CMV disease. Three (23.1%) patients achieved EB viremia after transplantation, one of them developed to EBV-related lymphocytic proliferative disease, while there were no patients showed invasive fungal infection. At the last follow-up, all patients survived, twelve of them were free from transfusion dependency. There were no transplant-related deaths. Projected overall and thalassemia-free survival at three years was 100% and 92.3%, respectively. The transplant protocol of haplo-HSCT by using parental donors in patients with thalassemia has reliable source of donors, high incidence of successful implantation and low incidence of GVHD, which can be used as an effective way to increase the source of donors in children with thalassemia.

Fluoroscopic predictors of acceptable capture threshold during the implantation of the micra transcatheter pacing system.

IntroductionFew predictors of low capture threshold before the deployment of the Micra transcatheter pacing system (Micra TPS) have been determined. We aimed to identify fluoroscopic predictors of an acceptable capture threshold before Micra TPS deployment.MethodsSixty patients were successfully implanted with Micra TPS. Before deployment, gooseneck appearance of the catheter shaft was quantified using the angle between the tangent line of the shaft and the cup during diastole in the right anterior oblique (RAO) view. The direction of the device cup toward the ventricular septum was evaluated using the angle between the cup and the horizontal plane in the left anterior oblique (LAO) view.ResultsOf the 95 deployments we evaluated, 56 achieved an acceptable capture threshold of ≤2.0 V at 0.24 ms. In this acceptable threshold group, the deflection angle of the gooseneck shaft was significantly larger and the device cup was placed more horizontally with a lower elevation angle compared with those in the high threshold group. A deflection angle of ≥6° and an elevation angle of ≤30° were identified as the predictors of an acceptable capture threshold after deployment. An acceptable capture threshold was achieved in 24/31 (77.4%) patients in whom either angle criterion was satisfied at the first deployment.ConclusionsDiastolic gooseneck appearance of the delivery catheter in the RAO view or near‐horizontal direction in the LAO view predicts an acceptable capture threshold after deployment. The shape of the delivery catheter before deployment should be evaluated using multiple fluoroscopic views to ensure successful implantation of Micra TPS.

Robotics for Cochlear Implantation Surgery: Challenges and Opportunities.

Recent advancements in robotics have set forth a growing body of evidence for the clinical application of the robotic cochlear implantation (RCI), with many potential benefits. This review aims to summarize these efforts, provide the latest developments in this exciting field, and explore the challenges associated with the clinical implementation of RCI. MEDLINE, PubMed, and EMBASE databases. A search was conducted using the keywords "robotics otolaryngology," "robotic cochlear implant," "minimally-invasive cochlear implantation," "minimally-invasive mastoidectomy," and "percutaneous cochlear implant" with all of their synonyms. Literature selection criteria included articles published in English, and articles from 1970 to present. The use of robotics in neurotology is a relatively new endeavor that continues to evolve. Robotics is being explored by various groups to facilitate in the various steps of cochlear implant surgery, including drilling a keyhole approach to the middle ear for implants, inner ear access, and electrode insertion into the cochlea. Initial clinical trials have successfully implanted selected subjects using robotics. The use of robotics in cochlear implants remains in its very early stages. It is hoped that robotics will improve clinical outcomes. Although successful implants with robots are reported in the literature, there are some challenges that need to be addressed before this approach can become an acceptable option for the conventional cochlear implant surgery, such as safety, time, efficiency, and cost. However, it is hoped that further advancements in robotic technology will help in overcoming these barriers leading to successful implementation for clinical utility.

Zoopery study on the treatment of intracranial aneurysms with a new blood flow guide device.

The purpose of this study was to evaluate the safety and effectiveness of arterial embolism device system produced by Taijie Weiye Technology Co., Ltd. Twenty healthy adult New Zealand white rabbits weighting from 3 to 4 kg were taken. Ligation and Elastic induction were used to build the aneurysm model of right common carotid artery in rabbits. The angiography and the arterial embolization device were implanted four weeks after the animal models were established. This device has excellent manufacturing, good controllability, and smooth pushing process. Five rabbits were randomly selected for angiography test to observe the healing of aneurysms in the first month, the third month and the sixth month after operation. Three other animal models with successful implantation were examined by arteriography in the first month, the third month and the sixth month, and the effect of implantation device on intercostal artery was recorded and analyzed. In the process of making aneurysm models, sixteen animals were successfully implanted with one device, two animals were given overlapping devices, and only two animals died in the process. The success rate of arterial embolic device system in the treatment of aneurysm was more than 80%. Among them, the two animals with 2 devices also achieved satisfactory therapeutic effect. According to this study, we found that the arterial embolization device system manufactured by Beijing Tajie Weiye Science and Technology Co., Ltd. was excellent in the immediate postoperative aneurysm occlusion rate and the long-term outcomes.

1155 Are common processes involved in both implanting an embryo and ovarian cancer?

Implantation is fundamental to successful establishment of both the trophoblast (placenta) and embryo. However, there are practical, ethical and legal restrictions to studying this process in humans. Implantation of free-floating cells originating from the oviduct leads to benign ectopic lesions (endosalpingiosis, ES) and may also play a key role in the pathogenesis of gynecologic malignancies. We hypothesized that by understanding the mechanisms driving ES, we would gain crucial insight into early pregnancy implantation and failures. We aimed to develop a mouse model to interrogate the role of implantation signaling factors in promoting benign ectopic lesions such as ES, as a novel model for early pregnancy and ovarian cancer. We developed an animal model of ES using auto-fluorescing (inherent in the donor mouse cells) oviductal tissue or oviductal epithelia cells (OECs). Utilizing this ES model, donor mice were treated with hormones to induce infertility by blocking implantation or with a vehicle control (Fig. 1). Oviductal tissue from these mice was harvested and implanted into the peritoneal cavity of recipient wild type mice. Recipient mice are monitored for a month before mice are imaged for the formation of auto-fluorescing legions resulting from the donor tissue. We observed 100% successful implantation rate in our ES mouse model of oviductal tissue was administered (Fig. 2). When isolated OECs were used, they required the co-injection of endometrium to successfully implant, however only 30% successfully implanted. We successfully created a model of ES that allows us to identify growth of lesions in vivo allowing us to study the mechanisms of implantation. We anticipate that by blocking key signals of implantation the formation of oviductal lesions in the peritoneal cavity will be blocked or significantly reduced. Success with this model will allow us to not only understand ES but has applications to the molecular mechanisms of pregnancy success and failures, alongside ovarian cancers derived from oviduct and endometrial cells.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

The Coronary Sinus Reducer; 5-year Dutch experience.

BackgroundRefractory angina is a growing and major health-care problem affecting millions of patients with coronary artery disease worldwide. The Coronary Sinus Reducer (CSR) is a device that may be considered for the relief of symptoms of refractory angina. It causes increased venous pressure leading to a dilatation of arterioles and reduced arterial vascular resistance in the sub-endocardium. This study describes the 5‑year Dutch experience regarding safety and efficacy of the CSR.MethodsOne hundred and thirty-two patients with refractory angina were treated with the CSR. The primary efficacy endpoint of the study was Canadian Cardiovascular Society (CCS) class improvement between baseline and 6‑month follow-up. The primary safety endpoint was successful CSR implantation in the absence of any device-related events.ResultsEighty-five patients (67%) showed improvement of at least 1 CCS class and 43 patients (34%) of at least 2 classes. Mean CCS class improved from 3.17 ± 0.61 to 2.12 ± 1.07 after implantation (P < 0.001). The CSR was successfully implanted in 99% of the patients and only minor complications during implantation were reported.ConclusionThe CSR is a simple, safe, and effective option for most patients with refractory angina. However, approximately thirty percent of the patients showed no benefit after implantation. Future studies should focus on the exact underlying mechanisms of action and reasons for non-response to better identify patients that could benefit most from this therapy.Electronic supplementary materialThe online version of this article (10.1007/s12471-020-01525-8) contains supplementary material, which is available to authorized users.

Abstract 5798: The role of implantation in endosalpingiosis, other benign gynecologic lesions, and ovarian cancer

Abstract High grade serous carcinoma (HGSC) arises from the ectopic implantation of malignant oviductal epithelial cells (OECs) in the peritoneal cavity and on the ovarian surface (the “tubal origins hypothesis”). We believe that these cells hijack the process of implantation used by the blastocyst, to implant ectopically in the peritoneal cavity, and certain women inherently have a high implantation capability enabling a higher rate of ectopic implantation and a higher risk for HGSC and other benign lesions in parallel. Endosalpingiosis (ES) is the benign counterpart to HGSC as both originate from OECs. We and others have demonstrated that ES lesions are significantly associated with gynecologic malignancy among patients over 51 years of age. We therefore increased the scrutiny on benign appearing adnexal lesions to align with the Sectioning and Extensively Examining-Fimbria (SEE-Fim) protocol. The pathology database was then queried for the presence of ES, endometriosis (EM), walthard nests (WN), paratubal cysts (PTC), and gynecologic malignancy for a one year period prior to and after this practice change. Prior to introducing the SEE-Fim protocol the prevalence of ES was 3%, compared to 22% when using SEE-Fim. Using the SEE-Fim protocol the prevalence of EM, WN, and PTC were 45%, 33%, and 42% respectively, substantially higher than previously reported. All lesions were observed to increase with age except EM which increased until menopause then decreased dramatically. An analysis on a subset of specimens which included ovarian tissue, the prevalence of implantation of at least one lesion type (ES, WN, or PTC) was more prevalent in patients age 51 and older (93%) compared to those 31-50 years of age. We additionally developed an animal model of ES using auto-fluorescing oviductal tissue. We assessed several conditions to determine the best environment for ES lesions to grow in vivo, including supplementing with estradiol and co-administering endometrium. In this model we were able to achieve a 100% successful implantation rate of ES when oviductal tissue was administered with estradiol supplementation independent of endometrial tissue presence. When isolated OECs were used, they required endometrium, and only 10% successfully implanted. We will additionally use a model of HGSC to ascertain the importance of implantation. The prevalence of ES, as well as PTC, WN, and EM, was substantially higher than previously reported, likely due to change of protocol in pathologic evaluation. Understanding how OECs implant ectopically and give rise to HGSC will lead to truly impactful advances in early detection, potential major breakthroughs in risk assessment, and a novel treatment avenue directed at preventing implantation. Citation Format: Jan S. Sunde, Morgan Wasickanin, Tiffany A. Katz, Emily L. Wickersham, Emilie Steed, Laurel Gillette, Christine Nadeau, Novae Simper. The role of implantation in endosalpingiosis, other benign gynecologic lesions, and ovarian cancer [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 5798.

Initial anticoagulation experience with standard-dose rivaroxaban after Watchman left atrial appendage occlusion

Warfarin is now recommended as the standard anti-thrombotic regimen to allow complete endothelialization over the Watchman device post percutaneous left atrial appendage occlusion (LAAO). However, the need for frequent monitoring, narrow therapeutic range, dietary restrictions and multiple drug interactions associated with warfarin have contributed to increasing uptake of non-vitamin K oral anticoagulants (NOACs) worldwide. At present, the feasibility and safety of NOACs instead of warfarin post-LAAO is lacking. Patients who underwent successful Watchman device implantation between October 1, 2016 and September 30, 2017 were enrolled in a retrospective database. And only patients who received rivaroxaban in the periprocedural period were included in this study. Transesophageal echocardiography (TEE) follow-up was scheduled at 6 weeks, at 6 months, and at 12 months post-implantation to detect device-related thrombosis (DRT) or peri-device leak. Meanwhile, thromboembolic and bleeding events were also evaluated at the time of follow-up. Totally, 57 Watchman devices were successfully implanted and 10 patients who were allocated to rivaroxaban at the dosage of 20 mg once daily were included. During the follow-up, none of the patients using rivaroxaban experienced DRT, peri-device leak, thromboembolic complications and major bleeding events, except for 2 patients who suffered minor bleeding during the 6 weeks follow-up. This study suggests that a short course of standard-dose rivaroxaban following Watchman LAAO is associated with low incidence of thrombotic complications and bleeding events, and might be a feasible alternative regimen in Chinese. Further randomized trials and large sample of real-world studies are needed to validate our finding.

Implantable pulmonary artery pressure monitoring device in patients with palliated congenital heart disease: Technical considerations and procedural outcomes.

We describe the technical considerations of transcatheter implantation of the CardioMEMS™ HF System (Abbott, Abbott Park, IL) in adult patients with complex palliated congenital heart disease (CHD) and advanced heart failure (HF). Ambulatory pulmonary artery (PA) pressure monitoring with implantable hemodynamic monitors (IHMs) has been shown to reduce HF-related hospital admissions in non-CHD populations. HF is a common late cardiovascular complication in adult CHD necessitating better understanding of IHM application in this population. We analyzed adults with complex CHD and advanced HF who were referred for CardioMEMS™ device implantation (2015-2018). Feasibility of device implantation, defined by successful device implantation and calibration, and procedural outcomes were evaluated. CardioMEMS™ was successfully implanted in all 14 adults (35.5 ± 9.2 years old, 72 ± 12 kg) with complex CHD (single ventricle/Fontan, n = 8 [57%]; d-transposition of the great arteries/atrial switch, n = 6 [43%]). The device was delivered via femoral venous access in 13 (93%) patients and implanted in the left PA in 12 (86%). A long sheath was used in 8 (57%) patients, including 5/6 with an atrial switch operation. There was one device migration that did not require retrieval. Transcatheter implantation of an IHM is feasible in select complex adult CHD patients with advanced HF. Further studies evaluating integration of ambulatory hemodynamics and the impact on clinical care are needed. This technology has the potential to improve medical management of advanced HF in patients with Fontan and atrial switch physiologies and provide new insights into their ambulatory hemodynamics.

P4526Implant procedure and lead handling characteristics of a novel active fixation quadripolar lead: Results from the Attain Stability Quad clinical trial

Abstract Background Dislodgements of left ventricular (LV) leads are still a challenging problem in cardiac resynchronization therapy (CRT). The Attain Stability Quad (ASQuad) MRI SureScan 4798 steroid-eluting, quadripolar LV lead has a side-helix to enable the lead to be actively fixated to the vessel wall. The uniquely designed active fixation can be advantageous in vessels that are wide or have short take-offs. Further, the helix easily elongates to allow for future extraction. Purpose To report on the handling, performance and safety of ASQuad LV lead in a large clinical study. Methods The ASQuad clinical study is a prospective clinical trial from 50 centers in 10 countries enrolling CRT candidates implanted with the ASQuad LV lead. Aside from evaluating safety and effectiveness of the LV lead, the trial specifically collected data on parameters related to lead stability during and post implant. Results Of 440 enrolled patients (74.8% male, average age 70±11 years) that underwent an implant attempt, 426 (96.8%) were successfully implanted. The helix was mostly affixed in the mid to basal lateral position (62%), followed by mid to basal posterior position (29%). The lead tip placement was most often mid lateral or mid posterior (77%), and in a vein with diameter greater than the pacing electrode diameter (&gt;5.1 French) in the majority (60%) of procedures. Among all subjects (n=421) who underwent pacing capture thresholds (PCT) tests before and immediate after guide catheter slitting, 98% reported ≤1 V difference in PCT, and 86% were within 0.5 V. The interquartile range for the difference in PCT was −0.1 to 0.1 V. The mean PCT at implant for all subjects at the final selected LV pacing vector was 1.15±0.70 V at 0.5 ms pulse width. The average LV lead implant time was 16±21 minutes. Targeted pacing location was achieved in 97% of successful implants, and 98% of implanters reported good or fair stability after guidewire removal. The overall handling of the LV lead was rated as acceptable by implanters in 99% of cases. Three patients (0.7%) experienced LV lead dislodgement post implant, and these complications were resolved by repositioning of the lead (0 and 1-day post implant) in two and by lead replacement when noted at 90 days follow-up in one. Conclusions The ASQuad LV lead was implanted with a high rate of success and ability to achieve the targeted pacing location. Lead handling and stability following guidewire removal were rated as acceptable by nearly all implanters. The side-helix likely improved LV lead stability since 98% of the subjects had ≤1 V difference in PCT before and after catheter slitting during implant procedures, and by demonstrating a low post implant lead dislodgement rate. Acknowledgement/Funding Sponsored by Medtronic

The early days of vascular and heart valve prostheses: a historical review.

This surgical heritage article provides a historical overview of the most important early advances of vascular- and valvular surgery, that lead to the development of currently used vascular- and valvular prostheses and materials. The first writings describing techniques in vascular surgery mainly focussed on hemorrhage control and date from around 1600 B.C. The strategy of vessel ligation was first mentioned in Western literature around 200 B.C. In the 18th century, techniques of ligation were expanded towards attempts of vessel restoration. The first artificial vascular prosthesis was made in 1894. From this time on, vascular prostheses were used in animal experiments and around 1900 for the first time in humans. More than 60 years later, in 1952, the first mechanical heart valve prosthesis was implanted. Four years later, the first successful biological heart valve implantation followed. In 2000, a transcatheter heart valve was successfully implanted in a human for the first time. Over time, procedures and techniques became more efficient and effective. This led to new developments, such as the manufacturing of a tissue engineered blood vessel in 1986. Nowadays, dozens of different valve prostheses have been devised, both mechanical and biological. Still, no ideal model of vascular and heart valve prosthesis exists.