TA and TAO-TAVI were performed using the Edwards Sapien XT prosthesis (n ¼ 219) (Sapien; Edwards Lifesciences, Irvine, Calif), Corevalve (n ¼ 5) (Corevalve; Medtronic, Minneapolis, Minn) or Symetis (n ¼ 5) (Symetis; Accurate TA, Ecublens, Switzerland). Information concerning the prosthetic valve system was not available for 1 patient. Procedure steps were generally performed as previously described, 7 and were adapted for the individual valve type and system.
Corevalve
Manufactured by Medtronic
Sourced in United States, Ireland, Switzerland
CoreValve is a medical device designed for the treatment of severe aortic stenosis. It is a prosthetic heart valve that is implanted via a minimally invasive procedure to replace the patient's diseased aortic valve.
Automatically generated - may contain errors
Lab products found in correlation
Evolut r, by Medtronic (35 mentions)
Sapien xt, by Edwards Lifesciences (30 mentions)
Sapien 3, by Edwards Lifesciences (25 mentions)
Evolut pro, by Medtronic (15 mentions)
Edwards sapien xt, by Edwards Lifesciences (10 mentions)
Sapien, by Edwards Lifesciences (6 mentions)
Corevalve evolut r, by Medtronic (6 mentions)
Lotus valve, by Boston Scientific (5 mentions)
Edwards sapien, by Edwards Lifesciences (5 mentions)
Evlolut pro, by Medtronic (4 mentions)
Sapien xt, by Medtronic (3 mentions)
Sapien 3, by Medtronic (3 mentions)
Sapien 3 ultra, by Edwards Lifesciences (2 mentions)
Evolut, by Medtronic (2 mentions)
Hancock 2, by Medtronic (2 mentions)
Evolute, by Medtronic (2 mentions)
Accurate neo, by Boston Scientific (2 mentions)
Trifecta, by Abbott (2 mentions)
Venus a valve, by Medtronic (2 mentions)
Acurate neo, by Boston Scientific (2 mentions)
109 protocols using corevalve
1
Transcatheter Aortic Valve Replacement
2
Finite Element Modeling of Transcatheter Heart Valves
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Finite element models of the CoreValve, Evolut R, Evolut PRO (Medtronic, Minneapolis, MN), and Lotus (Boston Scientific, Marlborough, MA) THVs, which had been previously developed, were used. 8 (link) In brief, frame morphology was derived from micro-CT scanning (30-μm resolution). Strut width was obtained from optical microscopy or based on data shared by the device manufacturer. Mechanical properties of the nickel titanium (Nitinol) frames were obtained though in vitro radial compression testing at body temperature, recording radial force throughout the compression cycle.
Patient-specific finite element models of the aortic root were constructed from preprocedural CT scans (Mimics v18.0; Materialise, Leuven, Belgium). The aortic wall, leaflets, and calcium were modeled with differing mechanical properties, as described previously. 10 The finite element model of the implanted THV was positioned within the aortic root model. Finite element analysis was performed using Abaqus/Explicit (v6.12; Dassault Systèmes, Vélizy-Villacoublay, France; available from https:// www.3ds.com). All steps of the procedure, including pre-and postdilatation were modeled.
Patient-specific finite element models of the aortic root were constructed from preprocedural CT scans (Mimics v18.0; Materialise, Leuven, Belgium). The aortic wall, leaflets, and calcium were modeled with differing mechanical properties, as described previously. 10 The finite element model of the implanted THV was positioned within the aortic root model. Finite element analysis was performed using Abaqus/Explicit (v6.12; Dassault Systèmes, Vélizy-Villacoublay, France; available from https:// www.3ds.com). All steps of the procedure, including pre-and postdilatation were modeled.
3
Aortic Valve Replacement Protocol
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Surgical intervention for AVR was done during extracorporeal circulation, cardioplegia and full anticoagulation, through median sternotomy and a transverse aortotomy 1-2 cm above the sinotubular junction, the diseased valve was excised and followed by the removal of calcium deposits from the aortic annulus. After that the prosthetic valve (stented) was inserted.
Transcatheter procedures was done in 8 patients with CoreValve and in seven patients with Direct Flow valver implantation. The choice of the valve type was based on operator preference and it was performed using standard protocol [22] . CoreValve is a tricuspid porcine prosthesis (CoreValve; Medtronic Inc, Luxembourg) mounted and sutured within a self-expandable frame made of nitinol while Direct Flow (Direct Flow Medical, Santa Rosa, CA, USA) has conformable sealing rings, which minimizes aortic regurgitation and permits full hemodynamic assessment of valve performance prior to permanent implantation. In both cases a balloon aortic valvuloplasty was performed and subsequently, the prosthetic valve (of a dimension accordingly to aortic annulus) was retrogradely introduced and deployed in the position of the native aortic valve.
Transcatheter procedures was done in 8 patients with CoreValve and in seven patients with Direct Flow valver implantation. The choice of the valve type was based on operator preference and it was performed using standard protocol [22] . CoreValve is a tricuspid porcine prosthesis (CoreValve; Medtronic Inc, Luxembourg) mounted and sutured within a self-expandable frame made of nitinol while Direct Flow (Direct Flow Medical, Santa Rosa, CA, USA) has conformable sealing rings, which minimizes aortic regurgitation and permits full hemodynamic assessment of valve performance prior to permanent implantation. In both cases a balloon aortic valvuloplasty was performed and subsequently, the prosthetic valve (of a dimension accordingly to aortic annulus) was retrogradely introduced and deployed in the position of the native aortic valve.
4
Transcatheter Aortic Valve Implantation
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Patients underwent Medtronic CoreValve or Evolut R (Medtronic Inc., Minneapolis, Minnesota) or Boston Lotus (Boston Scientific Corporation, Natick, MA) valve implantation. Trans-femoral was the default approach with other techniques (subclavian and direct aortic) chosen in the case of unsuitable femoral access. All procedures were performed by 2 experienced operators. Left ventricular end diastolic pressure (LVEDP) was measured invasively at the beginning and end of the procedure.
5
Transcatheter Aortic Valve Implantation Outcomes
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From April 2009 till January 2014, 102 consecutive patients with severe symptomatic aortic stenosis underwent TAVI in University Hospital Královské Vinohrady in Prague and agreed to participate in this study. All patients signed informed consent, data were prospectively entered into a dedicated anonymized database, the study design was academic without any industry sponsorship, in compliance with the Declaration of Helsinki, and protocol was approved by the local ethics committee. All patients were treated with supra-annular self-expandable CoreValve (Medtronic, Dublin, Ireland) prosthesis; sizes of 23, 26, 29, and 31 mm were available. Aortic regurgitation was semi-quantitatively evaluated by angiography at least 10 min post-implantation and graded according to Sellers;10 (link),11 (link) grade ≥2 was considered as a positive finding. Eight patients did not survive till 1-year follow-up and were excluded from the analysis. The cause of death was two periprocedural complications; three cardiovascular; two non-cardiac; and one unknown. No excluded patient had clinical signs of haemolysis and only one excluded patient had moderate (or severe) aortic regurgitation post-TAVI. All remaining 94 patients represent our study cohort.
6
Transfemoral CoreValve Implantation for Severe Aortic Stenosis
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Inclusion criteria: patients with acquired severe aortic stenosis (age 18 yr and above), undergoing transfemoral CoreValve™ (Medtronic, Minneapolis, USA) implantation. The decision for transcatheter treatment was made by the cardiac surgeons. Patients had to be eligible to undergo the procedure using general anaesthesia or sedation and be able to undergo neurocognitive testing. Comparable operative risk was determined from comorbidities and risk-scores (EUROscore, STS-Score were excluded from the study. Additional exclusion criteria were former/current alcohol or drug abuse, neurocognitive/neurodegenerative disease or psychiatric disorder, and use of antidepressants/sedatives. Secondary exclusion criteria were abortion of procedure, perioperative emergency conversion from sedation to general anaesthesia and the need for cardiopulmonary resuscitation during the observation period, as the primary endpoint could not be determined in these conditions. A sealed envelope containing the treatment assignment was allocated to the patients in the order of enrolment and opened at the patient's arrival in the operation room. The Institute of Medical Statistics and Epidemiology, Technische Universität München, provided the envelopes.
7
Transcatheter Aortic Valve Implantation Protocols
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The self-expanding, percutaneous CoreValve (Medtronic, Minneapolis, USA)
prosthesis, the Acurate (Symetis SA, Lausanne, Switzerland) prosthesis, or the
balloon-expandable Edwards Sapien-XT (Edwards Lifesciences, Irvine, EUA) valve
prosthesis were used, at the interventional cardiologist’s discretion.
Most procedures were performed under general anesthesia and with transesophageal
echocardiography. Transfemoral vascular access was indicated in all patients who
had a favorable vascular access. Arterial hemostasis was performed using a
specific device, mediated by the Perclose ProGlide® Suture-Mediated
Closure System (Abbott Vascular™, Santa Clara, USA) or surgical access.
When transfemoral access was not possible, the transapical, transaortic or the
subclavian accesses were used as alternatives. Both predilatation and
postdilatation were performed at the intervention team’s discretion. Whenever
possible, patients were extubated in the operating room and kept in observation
in the intensive care unit during 24-48 hours. Hospital discharge occurred
according to patient’s clinical progress after TAVI. Hemodynamic data were
obtained during the TAVI procedure and by echocardiography before hospital
discharge.
prosthesis, the Acurate (Symetis SA, Lausanne, Switzerland) prosthesis, or the
balloon-expandable Edwards Sapien-XT (Edwards Lifesciences, Irvine, EUA) valve
prosthesis were used, at the interventional cardiologist’s discretion.
Most procedures were performed under general anesthesia and with transesophageal
echocardiography. Transfemoral vascular access was indicated in all patients who
had a favorable vascular access. Arterial hemostasis was performed using a
specific device, mediated by the Perclose ProGlide® Suture-Mediated
Closure System (Abbott Vascular™, Santa Clara, USA) or surgical access.
When transfemoral access was not possible, the transapical, transaortic or the
subclavian accesses were used as alternatives. Both predilatation and
postdilatation were performed at the intervention team’s discretion. Whenever
possible, patients were extubated in the operating room and kept in observation
in the intensive care unit during 24-48 hours. Hospital discharge occurred
according to patient’s clinical progress after TAVI. Hemodynamic data were
obtained during the TAVI procedure and by echocardiography before hospital
discharge.
8
Mortality Outcomes in Severe Aortic Stenosis TAVI
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In this single-center cohort study, patients with severe aortic stenosis scheduled for TAVI at the Division of Cardiology, Medical University of Graz were prospectively recruited to undergo pre-procedural CMR between May 2011 and March 2015, in the absence of CMR contraindications (incompatible metal implants such as pacemakers, severely reduced kidney function, claustrophobia). Patients who underwent a successful transfemoral TAVI procedure with a CoreValve (Medtronic) prosthesis were included in the study. Cases with a CMR image quality insufficient to allow reliable analysis were excluded.
The primary endpoint was all-cause mortality (18 (link)) at 1 year, which corresponds to the recommended minimum life expectancy for patients eligible for TAVI (19 (link)). Additionally, cardiovascular mortality was defined according to VARC-2 criteria (20 (link)) and served as a secondary endpoint. After a follow-up of at least 3 years, mortality data were gathered via review of medical records, via phone contact, or by request at the national death register. All patients gave written informed consent. The study was approved by the ethics committee of the Medical University of Graz (No. 25-437ex12/13) and complies with the Declaration of Helsinki.
The primary endpoint was all-cause mortality (18 (link)) at 1 year, which corresponds to the recommended minimum life expectancy for patients eligible for TAVI (19 (link)). Additionally, cardiovascular mortality was defined according to VARC-2 criteria (20 (link)) and served as a secondary endpoint. After a follow-up of at least 3 years, mortality data were gathered via review of medical records, via phone contact, or by request at the national death register. All patients gave written informed consent. The study was approved by the ethics committee of the Medical University of Graz (No. 25-437ex12/13) and complies with the Declaration of Helsinki.
9
Retrospective Study of TAVI Outcomes
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We retrospectively reviewed consecutive patients who underwent TAVI between January 1, 2016 and July 31, 2019 at St. Marianna University Hospital. TAVI was performed using balloon-expandable (Sapien XT and Sapien 3; Edwards Lifesciences, Irvine, CA, USA) and self-expandable devices (CoreValve, Evolut R, Evolut Pro, and Evolut Pro Plus; Medtronic, Minneapolis, MN, USA). The decision for TAVI was comprehensively made based on the patient’s activities of daily living, age, and the Society of Thoracic Surgeons (STS) score, and the procedural strategies, including valve type selection, were decided by a multidisciplinary heart team including cardiothoracic surgeons, anesthesiologists, interventional cardiologists, and echocardiography cardiologists. Patients who underwent emergency or urgent TAVI were excluded from the study because a poorer prognosis is expected for these patients and baseline echocardiographic data were insufficient.5 The study was approved by the appropriate institutional review board and conducted in accordance with the Declaration of Helsinki. Informed consent was acquired in the form of opt-out on the website.
10
Transcatheter Aortic Valve Implantation Procedure
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TAVI was performed by a multidisciplinary heart-team in a hybrid operating room using standard techniques8 (link),9 (link), predominantly under conscious sedation10 (link) with percutaneous femoral artery access and closure11 (link). One of two currently CE-approved bioprosthesis (Edwards Sapien and Medtronic CoreValve) was implanted.
All patients were periprocedurally monitored with a 6-electrode virtual 12-lead electrocardiogram and pulse oximetry; an indwelling urinary catheter was inserted. A radial artery catheter and a triple lumen central venous catheter in the internal jugular vein (under ultrasound guidance) were placed, along with a pulmonary artery balloon catheter and a provisional pacemaker catheter10 (link).
All patients were routinely transferred to the intensive care unit (ICU) after the procedure for postinterventional surveillance and further care for a minimum of 24 hours.
All patients were periprocedurally monitored with a 6-electrode virtual 12-lead electrocardiogram and pulse oximetry; an indwelling urinary catheter was inserted. A radial artery catheter and a triple lumen central venous catheter in the internal jugular vein (under ultrasound guidance) were placed, along with a pulmonary artery balloon catheter and a provisional pacemaker catheter10 (link).
All patients were routinely transferred to the intensive care unit (ICU) after the procedure for postinterventional surveillance and further care for a minimum of 24 hours.
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