Lotus valve

OBJECTIVES: The management of severe aortic stenosis has been revolutionized by the introduction of transcatheter aortic valve implantation (TAVI), especially in patients at intermediate, high, or prohibitive surgical risk. There is uncertainty, however, regarding the comparative effectiveness and safety of contemporary TAVI devices. METHODS: We queried detailed data from the ongoing national Italian TAVI registry and compared baseline features, procedural details, and 12-month outcomes of Acurate Neo (Boston Scientific), Evolut Pro/R (Medtronic), Lotus (Boston Scientific), Portico (Abbott Vascular), and Sapien/ Sapien S3 Ultra (Edward Lifesciences) transcatheter aortic valves...

Background The need for new permanent pacemaker implantation (PPI) after Transcatheter Aortic Valve Implantation (TAVI) remains a critical issue. Membranous Septum (MS) length is associated with PPI after TAVI. The aim of this study was to identify different MS thresholds for the contemporary THV-platforms. Methods This retrospective, case-control study enrolled all patients who underwent a successful TAVI procedure with contemporary THV-platforms in the Erasmus University Medical Center between January 2016 and March 2020...

BACKGROUND: The clinical predictors and sequelae of leaflet thrombosis (LT) following transcatheter aortic valve replacement (TAVR) is still unclear. Therefore, our aim was to determine the clinical predictors and sequelae at mid-term follow-up of computed tomography (CT)-defined LT following TAVR. METHODS AND RESULTS: We performed a prospective evaluation with a 320-multislice CT following TAVR for the presence of LT, defined as hypo-attenuated leaflet thickening (HALT)...

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OBJECTIVES: The aim of this study was to evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system. BACKGROUND: The LOTUS Edge system was commercially re-released in April 2019. The authors report the first European experience with this device. METHODS: A multicenter, single-arm, retrospective registry was initiated to evaluate short-term clinical outcomes. Included cases are the first experience with this device and new implantation technique in Europe...

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No abstract text is available yet for this article.

Paravalvular leak (PVL) is an important complication of transcatheter aortic valve implantation (TAVI) and is associated with poor prognosis. We aimed to identify the risk factors for PVL after TAVI including patient (calcium amount or location), device (leakage-proof or not), and procedural (oversizing index (OI)) factors. The primary outcome was mild or greater PVL at 1-month follow-up echocardiography. Overall, 238 patients who underwent TAVI using eight types of valves (Edwards Sapien, Sapien XT, Sapien 3, CoreValve, Evolut R, Evolut PRO, Lotus, and Lotus Edge) were included...

OBJECTIVES: To compare device success and paravalvular leak rates of 3 new-generation transcatheter aortic valve replacement devices in patients with bicuspid aortic valve stenosis and to test their biomechanical performance in a computer-based simulation model of aortic root with increasing ellipticity. METHODS: This retrospective multicentre study included 56 bicuspid aortic valve patients undergoing transcatheter aortic valve replacement with new-generation devices: Lotus/Lotus Edge (N = 15; 27%), Evolut-R (N = 20; 36%) and ACURATE neo (N = 21; 37%)...

BACKGROUND: The REPRISE Japan study, a prospective multicenter single-arm trial, was undertaken to confirm the safety and effectiveness of transcatheter aortic valve replacement (TAVR) with the LOTUS valve in Japanese subjects with severe symptomatic calcific aortic stenosis at extreme or high surgical risk.Methods and Results:REPRISE Japan enrolled 40 subjects in the transfemoral (TF) cohort (mean age 84 years; mean [±SD] Society of Thoracic Surgeons [STS] score 6.4±2.9%); 10 additional subjects were treated with a transaortic (TAo) approach (mean age 84 years; mean STS score 6...

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Rates of permanent pacemaker (PPM) implantation following transcatheter aortic valve implantation (TAVI) are higher than following surgery and are dependent on patient factors and valve type. There is an increasing trend towards pre-emptive PPM insertion in patients with significant conduction disease prior to TAVI. We report results from the British Cardiovascular Intervention Society (BCIS) on pre- and post-procedural PPM implantation in the TAVI population. All centres in the United Kingdom performing TAVI are required to submit data on all TAVI procedures to the National database which are then reported annually...

The risk of recurrent mitral regurgitation after surgical mitral valve repair for ischemic functional mitral regurgitation is 28 % at 10 years. Also, an increasing number of patients with degenerated mitral bioprostheses are seen in daily clinical practice due to a dramatic shift from mechanical to biological bioprostheses over the past few decades. Therefore, it can be anticipated that there will be growing need for therapy options to treat high-risk patients in case of recurrent mitral regurgitation subsequent to surgical mitral valve repair or replacement...

AIMS: To investigate the total amount, size and heterogeneity of debris captured among different transcatheter valve types and while repositioning. METHODS AND RESULTS: A total of 328 patients who underwent transcatheter aortic valve implantation (TAVI) with Sentinel cerebral embolic protection (CEP) at our center were eligible. Histopathological and semiquantitative analysis of captured debris was performed and data was entered in our prospective database. TAVI was performed with either the Evolut R/PRO (N=123), Sapien3 (N=113) or Lotus valve (N=92)...

Background Gait speed is a reliable measure of physical function and frailty in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). Slow gait speed pre-TAVR predicts worse clinical outcomes post-TAVR. The consequences of improved versus worsened physical function post-TAVR are unknown. Methods and Results The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Randomized Clinical Evaluation) trial randomized high/extreme risk patients to receive a mechanically-expanded or self-expanding transcatheter heart valve...

BACKGROUND: The need for permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI) is a recognized complication due to compression of the cardiac conduction system. PPI rates vary according to type of TAVI device, implantation technique, and patient-related factors. METHODS: We analyzed the baseline characteristics, and then the preprocedure and daily postprocedure electrocardiograms (ECGs) of 101 consecutive patients who underwent TAVI using the Lotus valve (Boston Scientific) between 2013 and 2015...

RESPOND is a prospective, single-arm study enrolling 1014 transcatheter aortic valve replacement (TAVR) patients. The objective of this analysis is to assess the impact of cerebral embolic protection (CEP) devices and prosthetic valve repositioning on the risk of neurologic complications in patients treated with the fully repositionable Lotus Valve in the RESPOND postmarket study. Valve repositioning and CEP use were at the operators' discretion. Stroke events were adjudicated by an independent medical reviewer...

OBJECTIVES: The aim of this study was to assess acute regurgitation following transcatheter aortic valve replacement, comparing different implanted transcatheter heart valves. BACKGROUND: Regurgitation following transcatheter aortic valve replacement influences all-cause mortality. Thus far, no quantitative comparison of regurgitation among multiple commercially available transcatheter heart valves has been performed. METHODS: Aortograms from a multicenter cohort of consecutive 3,976 transcatheter aortic valve replacements were evaluated in this pooled analysis...

OBJECTIVE: Transcatheter aortic valve implantation (TAVI) is an established alternative to surgical aortic valve replacement. Our study aimed to evaluate the implementation of TAVI at our large-volume center, having an all-comer patient population with short and long-term follow-ups. METHODS: This retrospective, single-center analysis included 556 consecutive patients with symptomatic severe aortic stenosis (AS) who underwent TAVI between July 2011 and December 2019...

BACKGROUND: Frequent occurrence of paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) was the main concern with early-generation devices and focused technological improvements. Current systematic review and meta-analysis sought to compare outcomes of TAVR for severe native valve stenosis with next-generation devices: Lotus and Sapien 3. METHODS: Electronic databases were screened for studies comparing outcomes of TAVR with Lotus and Sapien 3...