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Lotus valve

Niklas Schofer, Florian Deuschl, Gerhard Schön, Moritz Seiffert, Matthias Linder, Andreas Schaefer, Johannes Schirmer, Edith Lubos, Hermann Reichenspurner, Stefan Blankenberg, Lenard Conradi, Ulrich Schäfer
BACKGROUND: The balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and the mechanically-expandable Lotus valve (Boston Scientific, Marlborough, MA, USA) are established devices for transcatheter aortic valve implantation. We sought to compare both transcatheter heart valves (THV) under consideration of the extent of THV landing zone calcification. METHODS: This retrospective analysis includes consecutive patients with severe aortic stenosis treated with Sapien 3 (S3; n=212) or Lotus (n=61) THV via transfemoral access...
March 13, 2018: Journal of Cardiology
Federico M Asch, Mani A Vannan, Siddharth Singh, Bijoy Khandheria, Stephen H Little, Dominic J Allocco, Ian T Meredith, Ted E Feldman, Michael J Reardon, Neil J Weissman
BACKGROUND : Comparative echocardiographic data on transcatheter aortic valve replacement systems from randomized trials are limited. The REPRISE III trial (Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Randomized Clinical Evaluation) is a multicenter, randomized comparison of a mechanically expanded (Lotus) versus self-expanding (CoreValve) transcatheter aortic valve replacement device. This analysis rigorously assesses Doppler-derived valve hemodynamics and the impact on outcomes at 1 year in patients with extreme/high surgical risk treated with Lotus and CoreValve from REPRISE III...
March 12, 2018: Circulation
Patrizia Presbitero, Loredana Iannetta, Paolo Pagnotta, Bernhard Reimers, Marco L Rossi, Dennis Zavalloni Parenti, Giovanni Bianchi, Francesco Bedogni
BACKGROUND: It is well known that bicuspid valve stenosis can be treated with transcatheter aortic valve implantation (TAVI) even if specific issues can cause problems: dilatation of ascending aorta, possible aorthopathy, eccentricity of the valve and calcium distribution in leaflets and in commissures. We classified Bicuspid aortic valve (BAV) in type 0 (2 cusps and no raphe), and type 1 (2 cusps and one or more raphes). The aim of the present study was to report the results of two types of valve (CoreValve from 2009 to 2016 and Lotus valve from 2014 to 2017) in a consecutive series of BAV patients treated in 2 Italian centers...
April 2018: Minerva Cardioangiologica
Jasmin Ortak, Giuseppe D'Ancona, Hüseyin Ince, Hüseyin U Agma, Erdal Safak, Alper Öner, Stephan Kische
BACKGROUND: Permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) remains an issue open for criticism. Aim of this study is to investigate a strategy to reduce PPMI rate after TAVI in general and more specifically after implantation of the LOTUS® prosthesis. METHODS: Through our learning curve, we have developed a structured protocol to reduce PPMI rate. The protocol includes: shallow implantation depth within the native annulus, strict adherence to the international guidelines for PPMI, PPMI not earlier than 5 days after TAVI, and intravenous chronotropic and steroidal treatment (orciprenaline 0...
March 5, 2018: European Journal of Medical Research
Mark Webster, Sanjeevan Pasupati, Nigel Lever, Martin Stiles
OBJECTIVE: This first-in-human study evaluated the safety and technical feasibility of the Tempo temporary cardiac pacing lead (BioTrace Medical), which includes a novel fixation mechanism and soft tip. BACKGROUND: Complications of temporary pacing leads include dislodgment, arrhythmias, and ventricular perforation. Temporary pacing applications have increased with transcatheter aortic valve replacement (TAVR) growth, for rapid pacing during balloon valvuloplasty (BAV) and valve deployment, and for periprocedural bradyarrhythmia support...
February 15, 2018: Journal of Invasive Cardiology
Lennart van Gils, Jochen Wöhrle, David Hildick-Smith, Sabine Bleiziffer, Daniel J Blackman, Mohamed Abdel-Wahab, Ulrich Gerckens, Stephen Brecker, Vinayak Bapat, Thomas Modine, Osama I Soliman, Andrey Nersesov, Dominic Allocco, Volkmar Falk, Nicolas M Van Mieghem
OBJECTIVES: The aim of this post hoc analysis from the RESPOND (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes) post-market study was to assess the final implantation depth on the contrast aortogram after Lotus valve (Boston Scientific, Marlborough, Massachusetts) transcatheter aortic valve replacement (TAVR) and to correlate with permanent pacemaker implantation (PPI) and paravalvular leak (PVL). BACKGROUND: Contrast aortography allows for the assessment of implantation depth and PVL during and after TAVR...
January 22, 2018: JACC. Cardiovascular Interventions
Mohammad Alasti, Hashrul Rashid, Karthikeyan Rangasamy, Emily Kotschet, David Adam, Jeff Alison, Robert Gooley, Sarah Zaman
OBJECTIVES: To determine permanent pacemaker (PPM) dependency following transcatheter aortic valve replacement (TAVR) with the Lotus™ valve system (Boston Scientific), and the impact of PPM implantation on long-term morbidity and mortality. BACKGROUND: Conduction abnormalities are among the most common complications following TAVR. Limited studies have assessed pacing dependency following TAVR. METHODS: Consecutive patients (n = 166) with severe aortic stenosis who underwent TAVR with the Lotus valve system were prospectively recruited from a single-center...
January 4, 2018: Catheterization and Cardiovascular Interventions
Rodrigo Bagur, Tawfiq Choudhury, Mamas A Mamas
No abstract text is available yet for this article.
September 2017: Journal of Thoracic Disease
Hashrul N Rashid, Liam M McCormick, Andrew H Talman, Abdul R Ihdayhid, Nitesh Nerlekar, Ameera S Amiruddin, James Cameron, Arthur Nasis, Ian T Meredith, Robert P Gooley
OBJECTIVE: To determine the effect of aorto-ventricular angulation (AA) on procedural success with the Lotus Valve system. BACKGROUND: AA, the angulation of the aortic valve basal plane, may affect the deployment of transcatheter aortic valve replacements (TAVRs). The Lotus Valve system is fully repositionable and delivered on a pre-shaped catheter which may alter the impact of AA on its deployment. The effect of AA on procedural and clinical outcomes with the Lotus valve is unreported...
December 6, 2017: Catheterization and Cardiovascular Interventions
Neil Ruparelia, Katharine Thomas, James D Newton, Kate Grebenik, Amar Keiralla, George Krasopoulos, Rana Sayeed, Adrian P Banning, Rajesh K Kharbanda
BACKGROUND / PURPOSE: The Lotus valve (Boston Scientific, Natick, MA, USA) is a contemporary transcatheter aortic valve implantation (TAVI) device that is fully repositionable and retrievable to aid implantation and optimise procedural results. The ability to implant the device without routine pre-dilatation is another possible advantage reducing associated risks and procedure times. The aim of this study is to report procedural and 30-day outcomes following TAVI in a consecutive patient group presenting with severe symptomatic aortic stenosis with the Lotus valve system without routine pre-dilatation...
November 4, 2017: Cardiovascular Revascularization Medicine: Including Molecular Interventions
Sagar N Doshi, Sudhakar George, Chun Shing Kwok, Anthony Mechery, Mamas Mamas, Peter F Ludman, Jonathan N Townend, Moninder Bhabra
OBJECTIVES: To assess the feasibility of axillary transcatheter aortic valve implantation (TAVI) using the Lotus valve. BACKGROUND: TAVI is used to treat patients with severe aortic stenosis, with transfemoral (TF) access being the safest and most widely used route. In patients unsuitable for this, there are reports that the axillary artery may be safest alternative access route. The Lotus device is a fully retrievable 2nd generation transcatheter heart valve which is licensed for femoral and transaortic access...
November 11, 2017: Catheterization and Cardiovascular Interventions
Francesco Giannini, Azeem Latib, Matteo Montorfano, Neil Ruparelia, Vittorio Romano, Matteo Longoni, Luca Ferri, Richard Jabbour, Antonio Mangieri, Damiano Regazzoli, Marco Ancona, Nicola Buzzatti, Lorenzo Azzalini, Akihito Tanaka, Eustachio Agricola, Alaide Chieffo, Ottavio Alfieri, Antonio Colombo
BACKGROUND: Second generation transcatheter aortic valve implantation (TAVI) devices have been designed to reduce the rate of paravalvular leak (PVL) and other complications. An important technological advancement has been the ability to fully reposition devices to facilitate optimal implantation depth and position to reduce the likelihood of PVL. OBJECTIVES: To compare procedural and 30-day outcomes according to the Valve Academic Research Consortium (VARC)-2 criteria following TAVI with the fully repositionable and retrievable Lotus and DFM devices...
September 20, 2017: Catheterization and Cardiovascular Interventions
Mirjam Keßler, Birgid Gonska, Julia Seeger, Wolfgang Rottbauer, Jochen Wöhrle
BACKGROUND: Permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation is of high clinical relevance, but PPMI rates differ widely between valve types. Although the Lotus valve can be repositioned, reported rates for PPMI are high. The predictors of PPMI after Lotus valve implantation have not been defined yet. METHODS: We analyzed the impact of preexisting conduction disturbances, depth of implantation, oversizing, and amount of calcification on PPMI in 216 patients with severe symptomatic aortic stenosis underdoing Lotus valve implantation...
October 2017: American Heart Journal
Giuseppe Tarantini, Luca Nai Fovino, Paola Tellaroli, Paola Purita, Giulia Masiero, Massimo Napodano, Chiara Fraccaro, Gino Gerosa, Sabino Iliceto
BACKGROUND: The fully retrievable and repositionable Lotus Valve System uses a unique mechanical expansion mechanism. Balloon aortic valvuloplasty (BAV) is recommended before valve deployment. There are no studies focusing on feasibility and efficacy of Lotus Valve implantation without previous BAV. METHODS AND RESULTS: Thirty consecutive patients (63.3% female; mean age, 80±6.2years) underwent transcatheter aortic valve replacement (TAVR) with the Lotus Valve without preparatory BAV...
November 1, 2017: International Journal of Cardiology
Jonas Neuser, Paolo Galuppo, Daniela Fraccarollo, Jens Willig, Tibor Kempf, Dominik Berliner, Johann Bauersachs, Julian Daniel Widder
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is the method of choice for patients with severe aortic valve stenosis, who are ineligible or at high risk for surgery. Though TAVR leads to a significant reduction in mortality, a notable amount of patients are re-hospitalized early after TAVR. Parameters or biomarkers predicting outcome are therefore needed to identify patients who benefit most. Specific monocyte subsets have been associated with cardiovascular diseases and were shown to possess prognostic value...
2017: PloS One
Corinne Marzahn, Cornel Koban, Martin Seifert, Akihiro Isotani, Michael Neuß, Frank Hölschermann, Christian Butter
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe aortic stenosis and high surgical risk. Currently, various prosthesis types are available. Atrioventricular block (AVB) requiring pacemaker (PM) implantation is a typical complication after TAVI. This study investigated the recovery of AV node conduction and mid-term outcome of patients with or without PM implantation after TAVI according to prosthesis type. METHODS: From July 2008 to May 2015, 856 transcatheter heart valves were implanted at our center (age: 80...
January 2018: Journal of Cardiology
Anja Stundl, Regina Schulte, Hannah Lucht, Marcel Weber, Alexander Sedaghat, Jasmin Shamekhi, Berndt Zur, Eberhard Grube, Fritz Mellert, Armin Welz, Rolf Fimmers, Georg Nickenig, Nikos Werner, Jan-Malte Sinning
OBJECTIVES: The aims of this study were to determine plasma elevations of biomarkers of myocardial injury associated with transfemoral (TF) transcatheter aortic valve replacement (TAVR) and to evaluate their prognostic value. BACKGROUND: Increases in biomarkers of myocardial injury are a common finding after TAVR, but their clinical significance is unclear. METHODS: In 756 consecutive TF TAVR patients, cardiac high-sensitivity troponin I (hsTnI) and creatine kinase MB (CK-MB) levels were measured at pre-defined time points to assess the occurrence of myocardial injury (defined as 15 times the upper reference limit for hsTnI [≥1...
August 14, 2017: JACC. Cardiovascular Interventions
Marco Barbanti, Sergio Buccheri, Josep Rodés-Cabau, Simona Gulino, Philippe Généreux, Gerlando Pilato, Danny Dvir, Andrea Picci, Giuliano Costa, Corrado Tamburino, Martin B Leon, John G Webb
OBJECTIVE: The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤30days) major outcomes after (TAVR) with second-generation devices. METHODS: A comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses...
October 15, 2017: International Journal of Cardiology
Mehmet Cilingiroglu, Konstantinos Marmagkiolis
Absence or minimization of PVL after TAVR and its potential association with higher rates of PPM placement has been the Achilles' heel of TAVR procedures. Pre-existing RBBB and depth of implantation are independent predictors of PPM need after Lotus valve implantation. Optimization of device design, increased operator experience, and focus on accurate device placement seem to result in decreased need for PPM after Lotus valve implantation.
July 2017: Catheterization and Cardiovascular Interventions
Neil Ruparelia, Katharine Thomas, James D Newton, Kate Grebenik, Amar Keiralla, George Krasopoulos, Rana Sayeed, Adrian P Banning, Rajesh K Kharbanda
OBJECTIVE: To report a first case series of the Lotus valve (Boston Scientific) for the treatment of surgical aortic bioprosthesis failure. BACKGROUND: Valve-in-valve (VIV) transcatheter aortic valve implantation (TAVI) is an established management option for surgical aortic bioprosthesis failure. Although TAVI has proven efficacious, complications relating to suboptimal valve implantation have been reported in approximately 5% of patients. The Lotus valve is fully repositionable and retrievable, and therefore enables complete assessment of valve function prior to definitive deployment...
July 15, 2017: Journal of Invasive Cardiology
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