Author + information
- Received February 18, 2015
- Revision received May 1, 2015
- Accepted May 5, 2015
- Published online August 24, 2015.
- Ganesh Manoharan, MBBCh, MD∗∗ (, )
- Antony S. Walton, MBBS†,
- Stephen J. Brecker, MBBS, MD‡,
- Sanjeevan Pasupati, MBChB§,
- Daniel J. Blackman, MD‖,
- Hongyan Qiao, PhD¶ and
- Ian T. Meredith, AM, MBBS, PhD#
- ∗Regional Cardiology Department, Royal Victoria Hospital, Belfast, United Kingdom
- †Victorian Heart Centre, Epworth Hospital, Melbourne, Australia
- ‡Cardiology and Interventional Cardiology Services, St. George’s Hospital, London, United Kingdom
- §Department of Cardiology, Waikato Hospital, Hamilton, New Zealand
- ‖Department of Cardiology, Leeds General Infirmary, Leeds, United Kingdom
- ¶Statistical Services, Medtronic, Inc., Minneapolis, Minnesota
- #Monash Cardiovascular Research Centre, MonashHEART, Monash Health, and Department of Medicine, Monash University, Melbourne, Australia
- ↵∗Reprint requests and correspondence:
Dr. Ganesh Manoharan, Cardiology Department, Royal Victoria Hospital, 274 Grosvenor Road, Belfast BT12 6BA, United Kingdom.
Objectives The purpose of this study was to prospectively evaluate the safety and clinical performance of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system (Medtronic, Inc., Minneapolis, Minnesota) in a single-arm, multicenter pivotal study in high- or extreme-risk patients with symptomatic aortic valve stenosis.
Background Although outcomes following TAVR are improving, challenges still exist. The repositionable 14-F equivalent CoreValve Evolut R TAVR system was developed to mitigate some of these challenges.
Methods Suitable patients (n = 60) underwent TAVR with a 26- or 29-mm Evolut R valve. Primary safety endpoints were mortality and stroke at 30 days. Primary clinical performance endpoints were device success per the VARC-2 (Valve Academic Research Consortium-2) and the percent of patients with mild or less aortic regurgitation 24 h to 7 days post-procedure.
Results Patients (66.7% female; mean age 82.8 ± 6.1 years; Society of Thoracic Surgeons Score 7.0 ± 3.7%) underwent TAVR via the transfemoral route in 98.3%, using a 29-mm valve in 68.3% of patients. All attempts at repositioning were successful. No death or stroke was observed up to 30 days. The VARC-2 overall device success rate was 78.6%. Paravalvular regurgitation post TAVR was mild or less in 96.6%, moderate in 3.4%, and severe in 0% at 30 days. Major vascular complications occurred in 8.3%, and permanent pacemaker implantation was required in 11.7% of patients.
Conclusions The repositionable 14-F equivalent Evolut R TAVR system is safe and effective at treating high-risk symptomatic aortic stenosis patients. Repositioning was successful when required in all patients, with low rates of moderate or severe paravalvular aortic regurgitation and low permanent pacemaker implantation. (The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study; NCT01876420)
The prevalence of patients presenting with aortic stenosis increases with age (1,2), and untreated symptomatic patients have a poor prognosis (3–5). Transcatheter aortic valve replacement (TAVR) is now an accepted treatment strategy for patients who are considered to be high risk or unsuitable for surgery (6–11).
Despite studies demonstrating good outcomes following TAVR, challenges such as vascular access complications (12,13), the need for permanent pacemaker post-TAVR (14,15), paravalvular leak (PVL) (16,17), stroke (18,19), and procedure-related complications (20,21) still remain. Technological advancements, with conformable valve frames and more accurate valve positioning, may improve outcomes.
The Medtronic CoreValve Evolut R System (Medtronic, Inc., Minneapolis, Minnesota) (Figure 1) was designed to mitigate some of these difficulties. Detailed design characteristics have been described previously (22). In brief, this system comprises the Evolut R valve and the EnVeo R Delivery Catheter System (DCS) with the InLine sheath. The trileaflet valve and sealing skirt are made out of porcine pericardial tissue, sutured in a supra-annular position on a compressible and self-expandable nitinol frame (Figure 1A). The Enveo R DCS enables the valve to be fully repositionable and recapturable before full release by turning the delivery handle (Figure 1B). The built-in InLine sheath allows for the whole system to be inserted into a patient without the need for a separate access sheath, reducing the overall profile of the system (Figure 1C), equivalent to the outer diameter of a 14-F sheath.
The objectives of this prospective, single-arm, multicenter pivotal study were to evaluate the safety and clinical performance of the CoreValve Evolut R TAVR system in patients with severe symptomatic aortic valve stenosis who are at high or extreme risk for surgical aortic valve replacement (SAVR). The 30-day outcomes are presented in this paper.
This prospective, single-arm, multicenter study was conducted at 6 centers in the United Kingdom, Australia, and New Zealand (Online Appendix A). The study was funded by Medtronic, and the protocol was developed in collaboration with the study investigators.
The study was conducted in accordance with the Declaration of Helsinki and was consistent with Good Clinical Practice and the applicable local regulatory requirements. Local ethics committee approval was obtained, and signed informed consent was obtained from each patient who met all study inclusion criteria and had no exclusion criteria (Online Appendix B) before enrollment and before performing any study-related investigations.
The study methods included the following measures to minimize potential sources of bias:
• An external clinical event committee, comprising a cardiologist, a cardiothoracic surgeon, and a neurologist, adjudicated all serious adverse events in the study.
• A data safety monitoring board provided oversight of all safety aspects of the study.
• All sites followed a standardized protocol for acquisition of echocardiographic endpoint data.
• An echocardiography core laboratory (Mayo Clinic, Rochester, Minnesota) evaluated all echocardiograms and echocardiographic study endpoint results.
• All study-related data were collected electronically, and independent full source data verification was periodically conducted at each site.
All eligible patients had symptomatic (New York Heart Association [NYHA] functional class ≥II) aortic stenosis defined as an aortic valve (AV) area of <1.0 cm2 (or AV index of <0.6 cm2/m2) and a mean AV gradient >40 mm Hg or maximal velocity of >4.0 m/s by resting echocardiogram. Patients with low flow/low gradient aortic stenosis were permitted if they had documented dobutamine or exercise stress echocardiography demonstrating a mean gradient >40 mm Hg or a maximal valve velocity >4 m/s and an AV area <1.0 cm2 (or AV area index <0.6 cm2/m2).
Risk assessment was determined on the basis of a Society of Thoracic Surgery (STS) score ≥8.0% or documented heart team agreement of high or extreme risk for SAVR due to frailty or comorbidities.
Primary clinical exclusion criteria were any contraindication for placement of a bioprosthetic valve, clinically significant untreated coronary artery disease, severe left ventricular (LV) function (ejection fraction <20%), end-stage renal disease, liver failure, bare-metal stent placement within 30 days or drug-eluting stent within 6 months before assessment, myocardial infarction within the past 30 days, severe dementia, or any condition that would preclude anticoagulation. Key anatomical exclusion criteria were a pre-existing prosthetic heart valve in any position, mixed AV disease (stenosis and regurgitation), severe mitral or tricuspid regurgitation, moderate or severe mitral stenosis, or bicuspid or unicuspid AV.
Multislice computed tomography (MSCT) of suitable patients was used to analyze the aortic annulus and peripheral vasculature to assess anatomic suitability. This information assigned patients to undergo TAVR via the transfemoral or an alternative access route (direct aortic or subclavian artery). Two valve sizes were available in this study (26 or 29 mm), and valve choice was determined by the MSCT-derived annular perimeter (26 mm: 62.8 to 72.3 mm; 29 mm: 72.3 to 81.6 mm), as per the manufacturer’s instructions for use.
Before patient enrollment, the study sponsor trained all investigative teams on the study methods, procedures, and requirements. All implanting physicians were trained on the use of the investigational TAVR system through didactic and simulator sessions. Throughout the study period, any newly learned procedural techniques were disseminated to the other investigators.
The choice of performing the procedure under general or local anesthesia was at the discretion of the implanting team. Although the EnVeo DCS with the InLine sheath allows for the valve to be delivered “sheathless,” implantation using standard techniques (pre-positioning of an 18-F access sheath) was allowed on the basis of the manufacturer’s instructions for use. Once all arterial and venous accesses were achieved, intravenous unfractionated heparin was administered to achieve a recommended activated clotting time of ≥250 s.
The “sheathless” technique required distinct steps before advancement of the TAVR system into the patient. Once access was obtained and pre-closure sutures deployed, a 14-F 30-cm standard sheath was advanced into the patient. This access was used to cross the AV, followed by positioning of a pre-shaped stiff support wire in the LV. The manufacturer’s instructions for use recommended balloon aortic valvuloplasty (BAV) before positioning of the valve. Once BAV was completed, the 14-F sheath was carefully removed, maintaining wire position in the LV. The EnVeo DCS with the InLine sheath, mounted with the Evolut R valve, was then advanced “sheathless” into the patient and implanted at the annulus. Following successful valve implantation, the EnVeo DCS was removed, and while maintaining wire position, the 14-F sheath was re-introduced. Following this, post-TAVR hemodynamics and angiographic and echocardiographic assessments were completed.
During the TAVR procedure, an electrocardiogram (ECG) was recorded at key procedural steps (pre-TAVR, pre-BAV, post-BAV, immediately post-deployment, and at completion) to prospectively assess if or when a rhythm change may have occurred.
During valve delivery, the Evolut R can be repositioned by either resheathing or recapturing to optimally place the valve. Resheathing was defined as when only part of the valve was retrieved back into the DCS capsule, and recapture was defined as when the valve was completely retrieved back into the DCS with the intent to re-cross the AV (if the valve fully migrated into the ascending aorta during deployment) or, if necessary, to completely remove the system from the patient safely. Repositioning to achieve an implant depth between 1 and 5 mm was recommended.
Following successful TAVR, the use of dual antiplatelet therapy was at the discretion of the implanting team. Generally, the best practice recommendation for the CoreValve system was used, with dual antiplatelet therapy continued for 3 months, followed by single antiplatelet therapy for life.
Follow-up evaluation included clinical assessment, echocardiography, and 12-lead ECG at discharge and 30 days, and is planned through 2 years post-procedure. Transthoracic echocardiography was performed pre-implant and at 24 h to 7 days after the implant to calculate device success. In addition, cardiac enzymes were monitored through 30 days, and creatine kinase-MB was collected if elevation in creatine kinase was detected. Modified Rankin scores (MRS) are documented at baseline, discharge, 30 days, 6 months, and 1 year, as well as at 1 and 3 months following any stroke events.
There were 2 primary safety endpoints: the rate of all-cause mortality and the rate of any stroke at 30 days. The primary clinical performance endpoints were the device success rate, as defined by the VARC-2 (Valve Academic Research Consortium-2) (23), at 24 h to 7 days and the percent of patients with no more than mild aortic regurgitation at the early post-procedure echocardiogram (24 h through 7 days).
The secondary safety endpoints were: 1) the rates of the VARC-2 composite early safety endpoint, which includes death, all stroke (disabling and nondisabling), life-threatening bleeding, acute kidney injury at stage 2 or 3 (including renal replacement therapy), coronary artery obstruction requiring intervention, major vascular complication, and valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR); and 2) the individual components at 30 days. Secondary clinical performance endpoints included the rate of successful recapture (if tried) and valve function by Doppler echocardiography at 30 days.
The analysis cohort for this report comprised all 60 patients implanted with the Evolut R transcatheter aortic valve (TAV). Baseline categorical variables are presented as percents and continuous variables as mean ± SD. Event rates are reported as Kaplan-Meier estimates.
The clinical performance endpoints of device success and the percent of patients with no more than mild aortic regurgitation were summarized with 2-sided 95% exact binomial confidence intervals. The comparisons for valve hemodynamic data (mean AV gradient and AV area) between baseline and early post-procedure were conducted using the paired t-test. All statistical analyses were performed using Statistical Analysis Systems software, version 9.2 (SAS Institute, Cary, North Carolina).
A total of 60 patients (66.7% female; mean age 82.8 ± 6.1 years) underwent TAVR with the CoreValve Evolut R system at 6 centers in the United Kingdom, Australia, and New Zealand between October 2013 and July 2014 (Online Appendix A). The study cohort included each implanter’s first experience with the Evolut R System. The overall study compliance for the 30-day follow-up visit was 98.3% (Figure 2).
The mean STS score and logistic EuroSCORE were 7.0 ± 3.7% and 20.5 ± 12.5%, respectively. The most prevalent STS factors at baseline were chronic lung disease in 26 (43.3%), atrial fibrillation or flutter in 22 (36.7%), and prior coronary artery bypass grafting in 17 (28.3%) patients. At baseline, 68.3% of patients had NYHA functional class III or IV symptoms, with 41 patients (68.3%) considered to be frail (Table 1).
The majority of cases were performed under general anesthesia (63.3%), with transfemoral being the predominant TAVR access route (98.3%) (Table 2). The EnVeo DCS was advanced sheathless using the InLine sheath in the majority of cases without difficulty. Pre-dilation of the native AV was performed in 96.7% of cases, and a 20-mm balloon was used in 60.3% of cases. The Evolut R TAVR system was advanced to the native AV annulus in all patients without difficulty.
The 29-mm valve was implanted in 68.3% of patients, and post-implant dilation was performed in 21.7% of cases. Valve repositioning was successfully performed 22 times in 15 patients by either resheathing or recapturing to optimize valve position (Table 2). There were no instances in which the valve needed to be completely retrieved, and there was no valve-related dysfunction requiring a repeat procedure. One patient required a second Evolut R valve implantation due to the first valve being deployed supra-annularly, causing marginal aortic migration of the valve upon full release and resulting in severe PVL. This patient was discharged without complication, with a 30-day echocardiogram showing mild PVL.
There was no death or stroke observed up to 30 days (Table 3). Symptom relief post-TAVR was observed, with 76.3% of patients improving by at least 1 NYHA functional class and 39.0% improving by at least 2 NYHA functional classes from baseline to 30 days. No patient had coronary occlusion, annulus rupture, or ventricular perforation during TAVR.
Major vascular complication was observed in 5 patients (8.3%). Two patients required access intervention following TAVR: 1 patient experienced a dissection of the right common femoral artery, treated successfully with angioplasty with no further sequelae, and the other had a failed percutaneous closure device leading to bleeding and hematoma, treated with blood products and left femoral artery stenting. Access groin hematoma was noted in the other 3 patients, with 2 requiring blood products.
Life-threatening or disabling bleeding was observed in 3 patients, occurring at the access site, permanent pacemaker site, or induced by the endotracheal tube.
At 30 days, a new permanent pacemaker implantation was required in 11.7% of patients. Six patients had third-degree atrioventricular block, and 1 had second-degree atrioventricular block post-procedure. All permanent pacemaker implants occurred between 1 and 5 days post-TAVR. Pre-procedure ECG abnormalities were present in 4 patients: 2 had first-degree atrioventricular block, 1 had right bundle branch block (RBBB), and 1 had both RBBB and first-degree atrioventricular block. When the depth of implant was reviewed, the average depth for those who received a pacemaker (left coronary cusp [LCS] 9.4 ± 3.1 mm; noncoronary cusp [NCS] 8.1 ± 3.5 mm) was significantly deeper than that of patients who did not receive a new pacemaker (LCS 4.3 ± 2.5 mm; NCS 3.3 ± 2.5 mm; p < 0.0001 for both comparisons).
The VARC-2 overall device success rate was 78.6% post-procedure (Table 4). In 5 patients, the effective orifice area (EOA) could not be determined to calculate the patient-prosthesis mismatch (PPM).
The Evolut R TAV effectively reduced the mean AV gradient from 49.1 ± 13.0 mm Hg at baseline to 9.2 ± 3.9 mm Hg early post-procedure (p < 0.0001). The AV area was also significantly improved from 0.6 ± 0.2 cm2 at baseline to 1.9 ± 0.5 cm2 early post-procedure (p < 0.0001). Figure 3 shows valve hemodynamics through 30 days. Mild or less PVL occurred post-TAVR in 96.6% of patients; 2 patients had moderate and none had severe PVL at 30 days (Figure 4).
This prospective, multicenter, first-in-man study has demonstrated that the resheathable Medtronic CoreValve Evolut R TAVR system is safe, with good clinical performance at treating high-risk symptomatic patients with severe aortic stenosis. No death or stroke were observed up to 30 days, and the overall VARC-2–defined device success rate at 24 h to 7 days post-procedure was 78.6%, with 93.2% of patients having mild or less PVL. The PVL improved at 30 days, with 96.6% having mild or less, 3.4% having moderate, and none having severe PVL.
Although study design, patient selection, and TAVR experience may differ, the 30-day mortality and stroke rates observed in this study compare favorably to those reported in other studies using first-generation (10,11,24,25) or next-generation (26–29) devices. Despite patients in this study having an STS score of 7.0 ± 3.7%, the absence of primary clinical events at 30 days may in part be due to the use of MSCT (for sizing and assessment of coronary ostia), careful adherence to best practices learned from global use of the Medtronic CoreValve device, appropriate patient selection, the self-expanding nature of the TAVR system, and the resheathable feature of the Evolut R system.
Stroke, coronary occlusion, annular rupture, and LV perforation during TAVR significantly affects patient outcomes post-TAVR. The low stroke rate observed in this study is consistent with that reported (0% to 4%) from other studies (26–29). Female sex, use of the balloon-expandable TAVR system, previous bioprosthetic AV, and low-lying coronary ostia are risk factors for coronary occlusion (30). Severe annular calcification, the use of a balloon-expandable TAVR system, and aggressive post-dilation are associated with annular rupture (31,32). None of these complications were observed in this study.
Device success, as intended by VARC-2, requires a composite of: 1) absence of procedural mortality; 2) correct position of a single prosthetic valve; and 3) intended performance of the prosthetic valve (no PPM mean valve gradient <20 mm Hg or peak velocity <3 m/s, and no moderate or severe prosthetic regurgitation). Failure to meet any 1 of these 3 parameters will categorize the device a failure. The device success rate for this study was lower than expected (Table 4) and was driven predominantly by the presence of calculated PPM in 9 patients. The challenges with calculating PPM are recognized, especially when transthoracic rather than transesophageal echocardiography is used to measure LV outflow tract diameter. Furthermore, these data were not available in 5 patients, further affecting the device success rate. Importantly, the mean EOA at 24 h to 7 days and at 30 days was good (1.9 ± 0.5 cm2), with low mean gradients of 9.2 ± 3.9 mm Hg and 8.1 ± 3.3 mm Hg, respectively.
Repositionability and safety
Repositioning with the Evolut R was performed 22 times in 15 patients safely and without difficulty to optimize final valve implant position. Repositioning in these 15 patients enabled an average final implant depth of 5.9 ± 3.4 mm for NCS and 6.3 ± 4.1 mm for LCS. The ability to resheath and reposition in turn contributed to the overall good clinical outcomes, with no death or stroke, low to moderate PVL rates, and low permanent pacing rates observed in this study.
The novel distal portion of the capsule (containing the crimped valve [Figure 1B]) expands to facilitate valve resheathing and recapturing of a partially released Evolut R valve, which reduces friction and mechanical stress encountered during repositioning, thereby reducing agitation of friable native valve tissue and potentially contributing to the absence of clinical stroke observed.
Permanent pacemaker implantation
The rate of permanent pacemaker implantation was 11.7% in our study. The rate of permanent pacemaker implantation post-TAVR with the CoreValve device ranges between 11% and 40% (33,34) and for the Edwards SAPIEN between 3% and 8% (35). More recently, the multicenter ADVANCE II (CoreValve Prospective International Post-Market Advance II Study) study, investigating the effect of best practice on rhythm disturbances with the CoreValve device, reported pacing rates of 13.3% (36). Similar low rates of pacing were also observed with other new TAVR devices (27–29); however, the Lotus system reported a pacing rate of 28.6% (26). Although the cause is multifactorial, pre-existing RBBB (37), final device depth, and oversizing are suggested triggers.
The lower pacing rate in this study could be attributed to: 1) the redesigned delivery system (with resheath and recapture capability) enabling more accurate positioning; and 2) the modified, more conformable nitinol frame design resulting in a more uniform outward force and reduced stiffness at the inflow portion of the valve, thus potentially reducing trauma to the conduction system as compared with the CoreValve system. Of the 7 patients who received a permanent pacemaker through 30 days, 4 had pre-existing conduction abnormalities and all had significantly lower final deployment depth as compared with the study average.
Moderate to severe PVL post-TAVR is associated with a poor prognosis (38,39). Potential causes include suboptimal positioning, undersizing, and eccentric calcification. A more conformable frame, MSCT-based sizing, and repositionability may mitigate some of these challenges, as observed in this study. The observed rates for PVL mild or less (96.6%) and moderate (3.4%) with the Evolut R compare favorably to the CoreValve (mild or less: 91%; moderate to severe: 9%) (11), and appear similar to SAPIEN S3 (mild or less: 96.6%; moderate: 3.4%) at 30 days (29).
Aortic valve pressure gradient and valve area were significantly improved following Evolut R TAV implantation (Figure 3). Absence of PPM at the early post-implant echocardiogram (in 55 evaluable patients) was 83.6%. Despite the challenges and inconsistency with deriving these data, they appear to be better than that reported in the Reprise II (60.7%) (26) or the PARTNER (40% to 56%) (40) studies. This may, in part, be due to the supra-annular function of the Evolut R valve. Furthermore, the mean gradient and EOA at 30 days for the Evolut R were equivalent to those reported for the CoreValve bioprosthesis in the CoreValve US Extreme Risk (8.7 ± 4.2 mm Hg and 1.86 ± 0.56 cm2) (25) and High Risk (8.9 ± 3.9 mm Hg and 1.95 ± 0.56 cm2) (11) studies.
The rates of major vascular complications (MVC) (8.3%) and life-threatening bleeding events (5.0%) are consistent with rates reported for the CoreValve system. The CoreValve Extreme Risk (25) and High Risk (11) studies reported MVC rates of 8.2% and 5.9%, respectively, and life-threatening bleeding events of 12.7% and 13.6%, respectively. Patients with MVC in our study had a slightly higher body mass index when compared with those who did not (28.2 ± 5.0 kg/m2 vs. 26.8 ± 4.8 kg/m2; p = 0.53), which may have contributed to the access-related events.
This was a first-in-man study of the use of the Evolut R TAV in patients at high or prohibitive risk of SAVR. The study size was relatively small, with a short (30-day) follow-up. Longer-term follow-up to 2 years is planned. Although all patients had MRS assessments pre- and post-TAVR, formal neurological assessments were not performed unless a change in MRS was observed. The absence of clinical neurological events may also be in part due to the small study numbers. Larger studies are required to further evaluate clinical outcomes.
This study confirms the clinical safety and performance of the next-generation Evolut R repositionable TAVR system in treating high-risk or surgically inoperable symptomatic aortic stenosis patients. Future studies will further help to validate the favorable outcomes observed in this study.
WHAT IS KNOWN? High-risk or inoperable patients with symptomatic severe aortic stenosis are increasingly treated by TAVR; however, challenges such as death, stroke, paravalvular leak, and need for permanent pacing exist.
WHAT IS NEW? TAVR with the 14-F–equivalent, repositionable Medtronic Evolut R system results in reduced event rates.
WHAT IS NEXT? Larger studies are required to evaluate and confirm the findings of this small pivotal study.
The authors would like to thank Jane Moore, MS, ELS, an employee of the sponsor who, under the direction of the authors, drafted the methods and results sections and prepared all tables and figures to meet journal requirements. The authors would also like to thank the clinical study management team of Charles Boldt, MS, and Kelly Hendrickson, MS.
This study was supported by Medtronic, Inc. Dr. Manoharan has received consultant fees and honoraria from Medtronic, St. Jude Medical, and Boston Scientific. Dr. Walton serves as a proctor and advisory board member for Medtronic. Dr. Brecker has received consultant fees from Medtronic and Boston Scientific. Dr. Pasupati serves as a consultant and a proctor for Edwards Lifesciences, Medtronic, and St. Jude Medical. Dr. Blackman has received consultant fees and honoraria from Boston Scientific and Medtronic. Dr. Qiao is an employee and shareholder of Medtronic, Inc. Dr. Meredith has received consultant fees and honoraria from Boston Scientific and Medtronic; and has received proctor fees from Boston Scientific.
- Abbreviations and Acronyms
- balloon aortic valvuloplasty
- delivery catheter system
- left ventricle
- Modified Rankin score
- multislice computer tomography
- New York Heart Association
- patient-prosthesis mismatch
- paravalvular leak
- surgical aortic valve replacement
- Society of Thoracic Surgeons
- transcatheter aortic valve
- transcatheter aortic valve replacement
- Received February 18, 2015.
- Revision received May 1, 2015.
- Accepted May 5, 2015.
- 2015 American College of Cardiology Foundation
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