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23 protocols using corevalve evolut r

1

Patient-Specific Aortic Root Modeling for TAVR

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We construct a three-dimensional model of a patient-specific aortic root from pre-procedural computed tomography (CT) images of a female patient selected for TAVR with a 26 mm Medtronic CoreValve Evolut R at UNC Medical Center (Figs. 1a and 1b). The images used in this study were obtained under UNC Institutional Review Board study number 18-0202. Since the native valve leaflets are not clearly captured in the patient’s images, we construct idealized volumetric native aortic valve leaflets (Fig. 1c) based on measurements from Sahasakul et al.33 (link) and trim them in SOLIDWORKS (Dassault Systèmes SOLIDWORKS Corporation, Waltham, MA, USA) to fit within the reconstructed anatomy. Supplemental Materials Section A provides additional details.
Our model of the Evolut R is constructed from a CT scan of a 26 mm Medtronic CoreValve Evolut R device performed at UNC School of Medicine’s Biomedical Research Imaging Center. We create a discrete representation of the stent frame (Fig. 2a) by placing a series of points along the stent in the CT images. We then generate a volumetric model of the device’s porcine pericardial sealing skirt (Fig. 2b) around the stent frame and of the device’s porcine pericardial leaflets (Fig. 2c) using measurements of the physical device. Additional details are included in Supplemental Materials Section B.
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2

Transcatheter Aortic Valve Implantation Procedures

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All patients were evaluated in detail by the heart team, including a cardiologist and by a cardiac surgery, and found the high risk for valve surgery. All TAVI procedures were performed in a hybrid catheterization laboratory and conscious sedation was commonly used in TAVI procedures. The following transcatheter valve designs were used: CoreValve Evolut R (Medtronic, Minneapolis, Minn, USA), Portico (St. Jude Medical, St. Paul, Minneapolis, Minn, USA), Sapien XT (Edwards Lifesciences, Irvine, Calif, USA), and Myval (Meril Life Sciences Private Ltd., Gujarat, India). Prostheses were sized using manufacturer’s recommendations. Post-dilatation under rapid pacing was considered in the case of remaining moderate or severe paravalvular aortic regurgitation and/or prosthesis under expansion. A temporary pacemaker was placed as a backup for high-grade AV block, when necessary. Implantation depth was measured using fluoroscopic images in the projection chosen for deployment and defined as the distance from the deepest portion of the noncoronary cusp to the intraventricular end of the bioprosthesis, as previously described.12 (link)
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3

Prosthetic Valve Size Selection Protocol

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Theoretical prosthesis size selection was based on the annular measurements assessed in the 20% phase (max-systole) and 70% phase reconstruction (end-diastole) on the retrospectively ECG-gated scan[6 (link), 10 (link), 11 (link)], and from the non-ECG-synchronized scan. To estimate the theoretical prosthesis size, industry guidelines were used (S1 Appendix) for the balloon-expandable (ESV; Edwards Sapien 3, Edwards Lifesciences Corp, Irvine, CA, USA) and for the self-expandable trans-catheter aortic valve (MCV; CoreValve Evolut R, Medtronic, Minneapolis, MN, USA). The ESV-guideline uses the annular area and DA for prosthesis sizing whilst the MCV-guideline uses the annular diameter and perimeter. MCV-guidelines define the perimeter as: annulus diameter x π. Prosthesis sizing was done for both the measured perimeter and for the calculated perimeter (calculated-perimeter).
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4

Outcomes of Transcatheter Aortic Valve Replacement in Elderly Patients

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Data from 394 consecutive high-risk patients with symptomatic aortic valve stenosis who underwent transfemoral (TF) TAVR in our center using the Medtronic Corevalve Evolut R (MER) or Medtronic Evolut Pro (MEP; Medtronic Inc., Minneapolis, MN, USA; n = 44), the Edwards SAPIEN 3 (ES3; Edwards Lifesciences Inc., Irvine, CA, USA; n = 258), the Symetis ACURATE neo (SAN; Boston Scientific Corporation, Natick, MA, USA; n = 71), the Direct flow (DF; Direct Flow Medical, Santa Rosa California, USA; n = 19), and the Portico (Abbot Vascular, Illinois, USA; n = 2) bioprostheses were analyzed retrospectively. Patients were divided into four age groups: age ≤75 (group 1, n = 28), 76–80 (group 2, n = 107), 81–85 (group 3, n = 148), and >85 years (group 4, n = 111). Due to the increased frailty, direct implantation without preparatory BAV was more frequently performed on patients aged over 85 years (group 4) due to procedure simplification. The decision for TAVR was made by an interdisciplinary heart team [1 (link), 8 (link), 9 (link)]. All TAVR procedures were performed according to standard techniques and guidelines [8 (link)–11 (link)].
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5

Transfemoral TAVR with Evolut Devices

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All 303 patients in this study underwent TAVR using transfemoral access with second (CoreValve™ Evolut™ R; Medtronic Inc., Minneapolis, MN, USA) or third (CoreValve™ Evolut™ Pro; Medtronic Inc., Minneapolis, MN, USA) generation devices. The procedure was performed as previously described [12 (link)].
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6

Transfemoral Transcatheter Aortic Valve Implantation

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We chose the transfemoral approach as the first option when patients did not have an excessively narrow access route for insertion of the sheath or aortic arch atheroma. We performed TAVI under general anaesthesia in a hybrid operating room, except for two patients who underwent conscious sedation due to pulmonary dysfunction. Transcatheter heart valves were classified as balloon-expandable (Edwards Sapien XT or Sapien 3 Transcatheter Heart Valve; Edwards Lifesciences, Irvine, California, USA) or self-expandable (Medtronic classic CoreValve or CoreValve EvolutR; Medtronic, Minneapolis, Minnesota, USA). Balloon-expandable valves were the first choice, and self-expandable valves were reserved for patients with a narrow aortic annulus. We performed simultaneous catheter measurement to evaluate the invasive mAVPG as well as a measurement of left ventricular end-diastolic pressure before and after TAVI. After successful TAVI, patients were given a saline solution by intravenous infusion (1 mL/kg/hour) until the start of ingestion. The brachial blood pressure was maintained at less than 130 mm Hg using calcium channel blocker, if necessary.
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7

Remote Ischemic Preconditioning for TAVI

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Aortic valves were implanted through the transfemoral approach and under general anesthesia as previously described [9 (link)]. Application of RIPC started with the induction of anesthesia. We performed three cycles of ischemia for five minutes followed by reperfusion for five minutes (Figure 2). To induce ischemia, the cuff of a standard blood-pressure-manometer (Boso, Jungingen, Germany) was inflated 20–30 mmHg above the systolic arterial pressure. Efficacy was assessed clinically by pulselessness of radial artery and acrocyanosis followed by reactive hyperemia. The time interval between the end of the RIPC procedure and the start of the TAVI intervention was less than 30 min. Patients of each group received either a self-expandable CoreValve Evolut R (Medtronic, Minneapolis, Minnesota, USA) (n = 44) or a balloon-expandable Sapien XT/Sapien 3 (Edwards Lifesciences Inc., Irvine, CA, USA) (n = 22) valve. We used Imeron 350 (Bracco S.p.A., Milan, Italy) as contrast agent.
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8

Comparative Analysis of TAVR Devices

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Four types of TAVR devices were implanted in this cohort of patients. The IA devices were the balloon-expandable Sapien/-XT/-3 (Edwards Lifesciences, Irvine, CA, United States), and the mechanically expandable LOTUS (Boston Scientifics, Marlborough, MA, United States). The SA devices were the self-expanding CoreValve/Evolut R (Medtronic, Minneapolis, MN, United States), and the self-expanding Acurate (Boston Scientifics, Marlborough, MA, United States). The choice and sizing of the bioprosthesis were based on multidetector computed tomography evaluation or, when this was not available (28 patients, years: 2007–2008), by integration of echocardiography, angiography, and/or simultaneous aortography during balloon valvuloplasty. In the absence of recent coronary intervention, discharge therapy consisted of 3–6 months of dual antiplatelet therapy, or the combination of oral anticoagulant and aspirin if anticoagulation was clinically indicated. Clinical and echocardiographic follow-up was routinely performed at 30 days, 6 months, 1 year, and yearly thereafter.
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9

Remote Ischemic Preconditioning in TAVR

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Aortic valves were implanted through the transfemoral approach and under general anesthesia, as previously described [13] . With the induction of anesthesia, RIPC was conducted with three cycles of ischemia followed byreperfusion for five minutes each. A pressure of 20-30 mmHg above the systolic arterial pressure was applied by using a standard blood-pressure-manometer cuff (Boso, Jungingen, Germany). Efficacy was clinically assessed: pulselessness of the radial artery, acrocyanosis and reactive hyperemia. The start of the TAVR intervention was less than 30 minutes after finishing RIPC. Patients received either a self-expandable CoreValve Evolut R (Medtronic, Minneapolis, MN, USA) (n = 44) or a balloon-expandable Sapien XT/Sapien 3 (Edwards Lifesciences Inc., Irvine, CA, USA) (n = 22) valve. Imeron 350 (Bracco S.p.A., Milan, Italy) was used as contrast agent.
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10

TAVR Procedures at SFVAMC: A Hybrid Approach

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Between November 25, 2013 and August 31, 2016, 100 TAVR procedures were performed at SFVAMC. During the same period, there were 82 surgical aortic valve replacement procedures performed at SFVAMC. All cases were performed in a hybrid OR built within the cardiac catheterization laboratory. Edwards SAPIEN, SAPIEN XT, SAPIEN 3 (Edwards Lifesciences, Inc, Irvine, CA); as well as Medtronic Corevalve and Corevalve Evolut R (Medtronic, Inc, Minneapolis, MN) TAVR platforms were used as each became commercially available. Percutaneous-transfemoral, surgical cutdown-transfemoral, and transapical approaches were used. In six cases, planned concomitant percutaneous coronary intervention or vascular intervention was also performed as hybrid procedures. Procedures were performed either with general anesthesia or monitored anesthesia care (MAC). Transesophageal echocardiography was used in cases that had general anesthesia. Patients were observed in intensive care unit (ICU) for at least 24 hours post-procedure.
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