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Sensor-Enabled 3D Printed Tissue-Mimicking Phantoms: Application in Pre-Procedural Planning for Transcatheter Aortic Valve Replacement
Published in Ayman El-Baz, Jasjit S. Suri, Cardiovascular Imaging and Image Analysis, 2018
Kan Wang, Chuck Zhang, Ben Wang, Mani A Vannan, Zhen Qian
Patients with severe aortic stenosis may be asymptomatic for many years. However, once the symptoms appear and are only treated medically, the condition of the symptomatic AS patient declines quickly. Mortality rates from the onset of symptoms are approximately 25% at 1 year and 50% at 2 years. Aortic valve replacement where the diseased aortic valve is replaced with a mechanical or tissue valve during a surgical procedure, is a viable treatment option for symptomatic AS patients. Conventional aortic replacement surgery requires sternotomy, cardioplegic arrest, and cardiopulmonary bypass. For severe AS patients with inoperable conditions or who are designated as high risk for surgery, transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI) or percutaneous aortic valve replacement (PAVR), has been established as the treatment of choice. In this procedure, an aortic valve is implanted using a transcatheter technique and the sternotomy and cardiopulmonary bypass procedures are avoided.
Device profile of the SAPIEN 3 transcatheter heart valve in low-risk patients with aortic stenosis: overview of its safety and efficacy
Published in Expert Review of Medical Devices, 2021
Alberto Alperi, Jules Mesnier, Vassili Panagides, Josep Rodés-Cabau
Transcatheter aortic valve replacement (TAVR) has become a broadly used approach for the treatment of patients with symptomatic severe aortic stenosis (AS). While this technique was initially conceived for patients with a prohibitive surgical risk, the good clinical outcomes achieved in this subset of patients compared to medical management [1] prompted the expansion of TAVR toward the treatment of operable patients. Several randomized trials in patients with high and intermediate surgical risk showed the non-inferiority of TAVR compared to surgical aortic valve replacement (SAVR) in such patients [2–4]. Lately, TAVR has progressively expanded toward the treatment of low-risk patients, defined as those exhibiting a Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) score < 4%. In fact, recent data from the STS-ACC TVT registry showed that more than 8,000 TAVR procedures were performed in low-risk patients in North America during the year 2019 [5].
Mitral valve surgery: current status and future prospects of the minimally invasive approach
Published in Expert Review of Medical Devices, 2021
Karel M. Van Praet, Jörg Kempfert, Stephan Jacobs, Christof Stamm, Serdar Akansel, Markus Kofler, Simon H. Sündermann, Timo Z. Nazari Shafti, Katharina Jakobs, Stefan Holzendorf, Axel Unbehaun, Volkmar Falk
The improvements in video assistance technology have vastly improved over the past few years ranging from full HD, 30° or 120° cameras or today’s full 3D vision [4,55]. For high definition fully endoscopic 3D MIMVS, a high definition 30° thoracoscope is positioned into the chest via a 10 mm port after entering the thorax at the same ICS as the right anterior axillary line but below the thoracotomy. In this way, the thoracoscope brightly illuminates the entire chest cavity and allows for subsequent work to be performed. Carbon dioxide (CO2) from the camera port floods the surgical field during the procedure. The technical challenges and lengthy learning curve presented by the fully video-assisted thoracoscopic approach to surgical treatment of MV disease means that it is currently restricted to experienced surgeons. 3D vision is promising technology that is well worth promoting in the field of cardiac surgery [55]. For totally endoscopic mitral valve replacement (TEMVR), Zang et al [55]. concluded that a 3D-HD video system appears to be superior to a 2D system with better surgical performance and similar operative safety. When performing TEMVR, 3D images provide valuable in-depth information regarding the LA and LV, as well as providing structural details regarding the papillary muscles, MV leaflets, and chordae tendineae [55].
The WATCHMAN left atrial appendage closure device for patients with atrial fibrillation: current status and future perspectives
Published in Expert Review of Medical Devices, 2020
Lisette I.S. Wintgens, Moniek Maarse, Martin J. Swaans, Benno J.W.M. Rensing, Vincent F. Van Dijk, Lucas V.A. Boersma
Finally, structural heart disease (e.g. coronary atherosclerosis, hypertrophic cardiomyopathy, valvular heart disease) is an independent risk factor for AF. The presence of structural heart disease in AF patients is very common, although these patients have been underrepresented in most clinical trials. Percutaneous catheter-based interventions have led to a revolution and evolution in clinical care, especially in patients with extensive comorbidities or frailty, who are deemed ineligible to undergo conventional cardiac surgery. Transcatheter aortic valve replacement (TAVR) has become the preferred strategy of patients with severe aortic stenosis (AS) and high surgery risk. In patients planned for TAVR, the prevalence of AF is estimated at 40–50% [48]. The number of patients with mitral valve regurgitation (MR) that suffers from AF may be even higher. Small feasibility registries have described patients with MR or AS who have undergone combined LAAC with mitral valve clipping and transcatheter aortic valve replacement, respectively [49–51]. WATCH-TAVR is an RCT currently enrolling 312 patients with TAVR indication who are eligible for OAC with VKA or NOAC. Patients will be randomized in a 1:1 ratio between WM and medical treatment. The primary endpoint will be a composite of all-cause mortality, stroke, and bleeding at 1 year. There may be a number of other catheter-based procedures, such as alcohol septal ablation or percutaneous coronary interventions, that may also be combined with LAAC, either in one single procedure or as separate staged procedures.