Transcatheter device closure has emerged as the preferred treatment for ostium secundum atrial septal defects with adequate margins, occasionally requiring surgical intervention to manage complications. We report a case of a young female patient who presented with systemic desaturation and exertional dyspnoea 5 years after device closure. Evaluation demonstrated anterior malposition of the septal occluder, with the right atrial rim of the device diverting the blood from the inferior vena cava to the left atrium. She underwent surgical extraction of the device and pericardial patch closure of the atrial septal defect.

A 32-year-old man, who had developed fulminant myocarditis leading to asystole, underwent implantation of an EVAHEART 2 left ventricular assist system with a double-cuff tipless inflow cannula and a concurrent Fontan operation. Approximately 2 years after the simultaneous EVAHEART 2 implantation and the Fontan operation, the patient underwent heart transplantation. There was no device-related thromboembolism or pump malfunction under adequate antithrombotic management during the postoperative support period. Computed tomography showed no malposition of the inflow cannula irrespective of the left ventricular chamber size. Macroscopically, the left ventricular cavity of the excised heart revealed a smooth inflow ostium with appropriate intimal proliferation and without pannus or wedge thrombus formation. These findings suggest the utility of the double-cuff tipless inflow cannula for long-term clinical applications, which may lead to favorable outcomes during long-term patient management. The double-cuff tipless inflow cannula, which does not protrude into the left ventricular cavity, potentially contributes to the prevention of suction events and the collision of the inflow cannula with the interventricular septum and left ventricular free wall. Further investigation is required to confirm the role of the unique EVAHEART 2 inflow cannula in reducing thromboembolic events.

This study sought to evaluate the safety and feasibility of percutaneous retrieval of left atrial appendage closure (LAAC) devices with an endoscopic grasping tool. Transcatheter LAAC is a mechanical stroke prevention strategy in patients with nonvalvular atrial fibrillation (AF) who are poor candidates for long-term oral anticoagulation. However, these LAAC devices can be inadvertently released into an unfavorable location, the device might migrate to a different (unfavorable) position within the left atrial appendage (LAA) or may embolize from the heart into the aorta. In such instances, it can be challenging to remove the LAAC device without open cardiac or vascular surgery. This study reports on a series of 4 cases in which an endoscopic grasping tool (Raptor) designed for gastrointestinal applications was used to percutaneously (non-surgically) remove LAAC devices that were either malpositioned or embolized. LAAC devices were safely and non-surgically removed using the grasping device in all 4 cases (Amulet: 1, Watchman: 3). Devices were successfully retrieved from the left inferior pulmonary vein, descending aorta, aortic arch, and the edge of the LAA ostium. Time of device retrieval post-LAAC implantation ranged from 24 h to 1 year. Special precautionary measures, such as preemptive pericardial access, embolic protection devices, and intraprocedural imaging, were used in 2 cases. This case series demonstrated that the endoscopic grasping tool appeared to be safe and useful to percutaneously retrieve LAAC devices.

The EVAHEART 2 (Sun Medical Technology Research Corporation, Nagano, Japan) is an investigational centrifugal ventricular assist device in the United States, introduced a new type inflow, named "double cuff tipless" inflow cannula intended to mitigate the risks of cannula malposition and subsequent ischemic stroke events associated with thrombi around the inflow cannula. To achieve these performance benefits of the "tipless" design, however, it is crucial to adhere to the recommended surgical procedure. We introduced a polymer-based patient model that mimics a dilated cardiomyopathy apex for inflow cannula implantation training. Here, we used the model to simulate appropriate and inappropriate techniques for inflow suturing. With the appropriate technique, the inflow ostium is aligned on the endocardial plane, and the cut myocardial surface is not exposed to the bloodstream. By contrast, with the inappropriate technique, which is represented as a worst-case suturing scenario, the inflow ostium is misaligned, thus exposing the cut myocardial cross-section to the bloodstream. This misalignment can predispose to platelet deposition, thrombus formation, and pannus formation with long-term support. Repeated training with this human apex model is important to confirm the inflow position and intraventricular finish before moving on to human cases. Along with rigorous preclinical training, technical adherence will help to ensure better clinical outcomes.

The EVAHEART 1 left ventricular assist device was miniaturized to the EVAHEART 2, with a new inflow cannula designed to mitigate the risks of malposition. To evaluate the safety of the new double-cuff tipless inflow cannula, in vivo studies were performed in healthy bovines. Eight consecutive studies were done: five short-term studies of hematological adaptation and three long-term studies of tissue adaptation. Each inflow cannula was purposefully implanted in the worst-case setting with marked malposition. Two studies terminated early: one because of an animal-specific ancillary component and one because of an accidental radial fracture. Six studies reached the study endpoint without major adverse events. One animal could not achieve proper anticoagulation because of warfarin resistance. Pump speed and power were maintained within stable, normal ranges. There were no major organ dysfunction or suction events. Necropsy results showed two cases of pannus formation around the inflow ostium because of warfarin resistance and hyperinflammation at the inflow cuff suture line. There was one case of trivial pannus; four cases were pannus-free, with no evidence of ventricular wall suction. No wedge thrombus formation occurred. The EVAHEART 2 tipless inflow cannula may reduce adverse events attributable to the inflow cannula, such as stroke.