Medtronics Valve

Paravalvular leaks (PVL) were more severe and frequent with medtronic core valves (MCV) when compared with Edward Sapien valves (ESV) immediately after transcatheter aortic valve replacement (TAVR). Severity and frequency of PVL improved in MCV overtime, but not in ESV. The decrease in frequency of PVL in MCV valves was earlier and more robust in the area surrounding the commissure between noncoronary cusp (NCC) to right coronary cusp (RCC) compared with other areas. Such preferential reduction of PVL was not seen in ESV...

OBJECTIVES: The authors sought to compare clinical and hemodynamic outcomes in patients receiving transcatheter aortic valve replacement (TAVR) for low-gradient (LG) aortic stenosis in the CoreValve EUS (Expanded Use Study) versus those with high-gradient (HG) aortic stenosis from the CoreValve U.S. Pivotal Extreme Risk Trial and CAS (Continued Access Study). BACKGROUND: The EUS examined the impact of TAVR in patients unsuitable for surgical aortic valve replacement who were excluded from the U...

Transcatheter aortic valve replacement (TAVR) is not currently approved for pure native valve aortic incompetence, and is typically performed on a compassionate basis in selected patients who are at high risk for conventional surgery. We describe the first use of TAVR to treat iatrogenic severe acute pure aortic incompetence following mitral valve surgery. A 71-year-old gentleman developed life-threatening acute aortic regurgitation (AR) within hours of a very challenging fifth open heart mitral valve replacement...

Transcatheter pulmonary valve replacement (TPVR) is now common practice in patients with significant pulmonary regurgitation (PR), stenosis (PS), or mixed pulmonary valve disease. While the Melody valve (Medtronic, Inc.) and its delivery system were specifically designed for use in the right ventricular outflow tract (RVOT), Sapien valves (XT and S3, Edwards Lifesciences, Inc.) and their delivery systems (Novaflex and Commander) were not. As a result, placement of Sapien valves in the RVOT can be challenging secondary to the stiffness of the current delivery system...

BACKGROUND: Today there is no manufacturer-supplied retrieval tool for the Micra™ pacemaker (Medtronic, Minneapolis, MN USA), therefore off-the-shelf catheters have been employed for retrievals. The proximal retrieval feature of the Micra™ can be snared and the device is then retracted from the myocardium, pulling the device through the tricuspid valve. This study characterizes the potential risks of Micra™ nitinol tine engagement with the tricuspid sub-valvular apparatus. METHODS: Fresh human hearts nonviable for transplant (n = 10) were obtained from our regional organ procurement agency (LifeSource, Minneapolis, MN USA)...

BACKGROUND: Successful transcatheter aortic valve replacement (TAVR) requires an understanding of how a prosthetic valve will interact with a patient's anatomy in advance of surgical deployment. To improve this understanding, we developed a benchtop workflow that allows for testing of physical interactions between prosthetic valves and patient-specific aortic root anatomy, including calcified leaflets, prior to actual prosthetic valve placement. METHODS: This was a retrospective study of 30 patients who underwent TAVR at a single high volume center...

Since reimbursements for transcatheter aortic valve implantation(TAVI) for severe aortic valve stenosis began in 2013, TAVI has spread rapidly in Japan. TAVI is currently performed in nearly 100,000 cases a year worldwide, and more than 4,000 procedures performed annually in Japan. The TAVI valves available in Japan are Edwards' "SAPIEN" and the Medtronic "Evolut R". The "SAPIEN" is a balloon-expanding valve and can be placed via a transfemoral or transapical approach. In contrast, the "Evolut R" is a self-expanding valve and can be placed via the transfemoral, transsubclavian or direct aortic approach...

The axillary artery seems an interesting alternative in nonfemoral transaortic valve replacement (TAVR) patients. This study describes our experience with this technique and its short-term follow-up results. This is a retrospective single center study. All axillary TAVR performed in our department between 2015 and 2017 were included in the study. Mean follow-up was 13.2 ± 9.5 months. All reporting was done according to the VARC-2 criteria. During the period covered, 43 patients had an axillary TAVR. Most patients were men (62...

Transcatheter aortic valve implantation (TAVI) has evolved into a standard therapy for aged patients with severe aortic valve stenosis who are not candidates for surgery. However, the reports about the safety of TAVI for patients with dextrocardia situs inversus are few. An 84-year-old man with dextrocardia situs inversus underwent a TAVI for severe aortic stenosis (AS) with an aortic valve area of 0.5 cm2 , and a mean pressure gradient of 46 mmHg. Preoperative computed tomography (CT) revealed an inverted (rightward) orientation of the ventricle apex as well as the great vessels...

An 84-year-old female patient suffered from dyspnea due to severe aortic stenosis. Several comorbidities and her advanced age made her acceptable for transcatheter aortic valve implantation (TAVI). The TAVI procedure was performed via a femoral access and a 26-mm CoreValve prosthesis (Medtronic, Minneapolis, MN, USA) was implanted. The prosthesis was deployed at a high position because of short distance between the annulus base and coronary arteries. Aortic angiography indicated normal contrast flow into both coronary arteries...

PURPOSE: To assess valvular flow characteristics and pressure drop in a variety of normal and stenotic prosthetic heart valves (PHVs) using 4D Flow MRI. MATERIALS AND METHODS: In-vitro flow phantoms with four different PHVs were studied: Medtronic-Hall tilting disc, St. Jude Medical standard bileaflet (STJM), Medtronic CoreValve Evolut R and Edwards SAPIEN 3. The valvular flow characteristics were investigated in normal and stenotic PHVs by using 4D Flow MRI. RESULTS: The results showed that each valve provided a different amount of signal loss in the 4D Flow MRI...

BACKGROUND: The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients. OBJECTIVES: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. METHODS: Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR...

AIM: To compare procedural outcomes of transcatheter aortic valve replacement (TAVR) patients treated with new-generation valves. METHODS: We performed a retrospective analysis on an Israeli multicenter registry comprised of four tertiary centers, comparing patient outcomes implanted with the Edwards SAPIEN S3 (ES3) vs. the Medtronic Evolut R (MER) valves. RESULTS: The study population included 735 patients (ES3 n = 223; MER n = 512)...

Computational modeling and simulation has become more common in design and development of bioprosthetic heart valves. To have a reliable computational model, considering accurate mechanical properties of biological soft tissue is one of the most important steps. The goal of this study was to present a non-invasive material characterization framework to determine mechanical propertied of soft tissue employed in bioprosthetic heart valves. Using integrated experimental methods (i.e., digital image correlation measurements and hemodynamic testing in a pulse duplicator system) and numerical methods (i...

OBJECTIVES: To evaluate the association between measurements performed during Medtronic CoreValve (MCV) deployment and paravalvular leak (PVL). BACKGROUND: The MCV can be recaptured and repositioned, allowing the TAVR operator to implant at a more favorable position. The association between angiographic measurements of MCV position while the valve is recapturable and PVL post deployment has not been investigated. METHODS: 493 patients undergoing TAVR with MCV (January 2011-July 2017) were included...

Transcatheter aortic valves provide superior systolic hemodynamic performance in terms of valvular pressure gradient and effective orifice area compared with equivalent size surgical bioprostheses. However, in depth investigation of the flow field structures is of interest to examine the flow field characteristics and provide experimental evidence necessary for validation of computational models. The goal of this study was to compare flow field characteristics of the three most commonly used transcatheter and surgical valves using phase-locked particle image velocimetry (PIV)...

OBJECTIVES: The aim of this study was to evaluate the debris captured by the Claret Sentinel cerebral embolic dual-filter protection device during transfemoral transcatheter aortic valve replacement (TAVR) with different valve types. BACKGROUND: Risk for embolization of debris during TAVR may vary by TAVR device. METHODS: The filters of 100 consecutive patients were collected and captured debris was analyzed by histopathology and histomorphometry...

We report the case of an 84-year-old female with symptomatic bradycardia due to a complete atrioventricular block, who carried absent right and persistent left superior vena cava (SVC). Implantation of a pacing lead, particularly within the right ventricle (RV) in a patient with this venous anomaly is accompanied by technical difficulties. However, the apparatus consisting of a fixed-curve sheath (Model C315-S10, Medtronic, Inc., Minneapolis, MN, USA) and a lumenless fixed-screw pacing lead (Model 3830, Medtronic), allowed a rapid delivery into the RV without any complications...

Conduction disturbance requiring permanent pacemaker (PPM) implantation is a common complication after transcatheter aortic valve implantation (TAVI) using Medtronic self-expanding CoreValve, and has remained common following the introduction of the new generation CoreValve Evolut R device. The aim of this study was to identify the determinants of PPM implantation after TAVI with CoreValve Evolut R. We retrospectively examined 114 patients who underwent transfemoral TAVI using CoreValve Evolut R. We excluded 17 patients with preprocedural PPM, 1 patient requiring Edwards SAPIEN 3 implantation after CoreValve Evolut R implantation, and 4 patients who died during the hospital admission...

For decades, surgical replacement of the pulmonary valve has been seen as the gold-standard technique. Until the advent of Medtronic's Melody valve, it was the only option. Whilst radical changes in surgical techniques have not been forthcoming, rapid and substantial developments in the techniques and available technology for percutaneous valves now cause us to ask if the gold-standard moniker now belongs in the cath lab. This manuscript explores the recent history and future of a revolution in this large area of congenital cardiac practice...