Author + information
- Received July 31, 2017
- Revision received October 15, 2017
- Accepted October 17, 2017
- Published online December 18, 2017.
- Hermann Reichenspurner, MD, PhDa,∗ (, )
- Andreas Schaefer, MD, MHBAa,
- Ulrich Schäfer, MDa,
- Didier Tchétché, MDb,
- Axel Linke, MDc,
- Mark S. Spence, MDd,
- Lars Søndergaard, MD, MSce,
- Hervé LeBreton, MDf,
- Gerhard Schymik, MDg,
- Mohamed Abdel-Wahab, MDh,
- Jonathon Leipsic, MDi,
- Darren L. Walters, MDj,
- Stephen Worthley, MDk,
- Markus Kasel, MDl and
- Stephan Windecker, MDm
- aDepartments of Cardiovascular Surgery and General and Interventional Cardiology, University Heart Center, Hamburg, Germany
- bCardiologie Générale et Interventionelle, Clinique Pasteur, Toulouse, France
- cDepartment of Internal Medicine/Cardiology, Heart Center and Leipzig Heart Institute, University of Leipzig, Leipzig, Germany
- dCardiology Department, Royal Victoria Hospital, Belfast, United Kingdom
- eDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark
- fCentre cardio-pneumologique, Centre Hospitalier Universitaire Pontchaillou, Rennes, France
- gDepartment of Cardiology, Medical Clinic IV, Municipal Hospital Karlsruhe, Karlsruhe, Germany
- hDepartment of Cardiology, Heart Center Bad Segeberg, Bad Segeberg, Germany
- iDivision of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada
- jDepartment of Cardiology, The Prince Charles Hospital, Chermside, Queensland, Australia
- kDepartment of Cardiology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
- lDepartment of Cardiology, German Heart Center Munich, Munich, Germany
- mDepartment of Cardiology, Bern University Hospital (Inselspital), Bern, Switzerland
- ↵∗Address for correspondence:
Dr. Hermann Reichenspurner, Department of Cardiovascular Surgery, University Heart Center Hamburg, Martinistrasse 52, 20246 Hamburg, Germany.
Background The CENTERA transcatheter heart valve (THV) is a low-profile, self-expanding nitinol valve made from bovine pericardial tissue that is 14-F compatible with a motorized delivery system allowing for repositionability.
Objectives The pivotal study evaluated safety and efficacy of this THV in high–surgical-risk study patients with severe symptomatic aortic stenosis.
Methods Implantations were completed in 23 centers. Clinical and echocardiographic outcomes were assessed at baseline, discharge, and 30 days. Major events were adjudicated by an independent clinical events committee. Echocardiograms and computed tomography scans were reviewed by core laboratories. The primary endpoint was all-cause mortality at 30 days.
Results Between March 25, 2015 and July 5, 2016, 203 patients with severe symptomatic aortic stenosis and increased surgical risk, as determined by the heart team, were treated by transfemoral THV implantation (age 82.7 ± 5.5 years, 67.5% female, 68.0% New York Heart Association functional class III/IV). At 30 days, mortality was 1%, disabling stroke occurred in 2.5% of patients, and New York Heart Association functional class I/II was observed in 93.0% of patients. Effective orifice area increased from 0.71 ± 0.20 cm2 to 1.88 ± 0.43 cm2 (p < 0.001). Mean aortic transvalvular gradient decreased from 40.5 ± 13.2 mm Hg to 7.2 ± 2.8 mm Hg at 30 days post-procedure (p < 0.001). Paravalvular aortic regurgitation at 30 days was moderate or higher in 0.6% of patients. A new permanent pacemaker was implanted in 4.5% of patients receiving the THV (4.9% for patients at risk).
Conclusions The herein described THV is safe and effective at 30 days with low mortality, significant improvements in hemodynamic outcomes, and low incidence of adverse events. Of particular interest is the low incidence of permanent pacemaker implantations. (Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve [CENTERA-2]; NCT02458560)
Transcatheter aortic valve replacement (TAVR) has been incorporated in international guidelines for treatment of patients with prohibitive and high or intermediate risk for surgical aortic valve replacement (SAVR) (1,2). Besides the established benefits of TAVR among patients at high surgical risk (3,4), recent evidence also suggests favorable outcomes of TAVR in intermediate-risk patients regarding rates of mortality, disabling stroke, acute kidney injury, severe bleeding, and new-onset atrial fibrillation (5,6). Since the first human TAVR procedure in 2002 using a bovine pericardial transcatheter heart valve (THV) (7), several THV technologies have been introduced into clinical practice, with various delivery and release mechanisms including balloon-expandable (BE), self-expandable (SE), and mechanically-expanding frame designs. Of note, recent next-generation THV systems have been associated with marked design improvements, such as lower introducer/delivery profiles, increased range of valve sizes, retrievability and repositionability, and features to mitigate paravalvular leak (PVL) risk (8).
Outcomes in terms of mortality and all-cause hospital readmission appear to be comparable between present BE and SE THV. However, commercially available SE bioprostheses are traditionally considered to be associated with several shortcomings, including more frequent need for second valve implantation, higher rates of PVL, and more frequent need for permanent pacemaker (PPM) implantation (9,10). Conversely, SE valves are advantageous, particularly for treatment of aortic stenosis in patients with narrow or severely calcified aortic annuli to ensure adequate post-interventional aortic valve area (AVA) and low transprosthetic pressure gradients and to minimize the risk of annular rupture. Current evidence regarding next-generation devices suggests an equalization of BE and SE THV regarding post-procedural PVL and rates of PPM implantation (11,12).
One of the most recent SE devices is the CENTERA THV (Edwards Lifesciences, Irvine, California). Previously, Binder et al. (13) evaluated the feasibility of this SE THV (model 9500G). In this report, the THV was implanted in 15 patients via femoral or axillary arterial percutaneous access (13). The investigators concluded that TAVR with this THV and the motorized delivery system is feasible and leads to good short- and mid-term clinical and hemodynamic outcomes.
The present study reports the 30-day results with this novel THV, which features a low-profile delivery catheter, a contoured self-expanding nitinol valve frame with bovine pericardial tissue leaflets, and a unique motorized delivery system allowing for stable valve deployment and repositionability, as shown in Figure 1.
Between March 2015 and June 2016, the CENTERA-2 (Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve) nonrandomized, prospective, multicenter trial enrolled 203 patients from 23 centers (Online Table 1) in Europe, Australia, and New Zealand. Some patients withdrew from the study or did not meet the screening criteria due to anatomic reasons, such as an ascending aorta <6 cm in length. The study was approved by the local ethics committees and the respective health authorities in participating countries. All patients provided written informed consent. The study was registered with clinicaltrials.gov (NCT02458560).
A computed tomography (CT) imaging core laboratory (St. Paul’s Hospital Cardiac CT Corelab, Vancouver, Canada) was used to establish standardized pre-implantation aortic annulus measurements. Recommended CT sizing ranges are shown in Online Figure 1. An independent core laboratory (MedStar Health Research Institute, Hyattsville, Maryland) was used for all of the echocardiographic measurements.
Key inclusion criteria consisted of estimated high surgical risk (Society of Thoracic Surgeons score ≥8, logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] ≥15), New York Heart Association (NYHA) functional class ≥II, severe symptomatic aortic stenosis characterized by AVA ≤1 cm2 (indexed AVA ≤0.6 cm2/m2), or mean gradient ≥40 mm Hg, or peak aortic jet velocity ≥4.0 m/s. As per protocol, the “heart team” (including at least a cardiac surgeon, a multidisciplinary team of cardiac surgeons, interventional cardiologists, anesthesiologists, and cardiac imaging specialists) assessed whether a patient could be determined to be at a high surgical risk. In summary, if the Society of Thoracic Surgeons score was <8 and/or the logistic EuroSCORE was <15, the heart team documented other clinical or anatomic risk factors for which the patient would be considered high risk for surgery.
Key exclusion criteria included evidence of a myocardial infarction ≤30 days before the intended treatment, untreated clinically significant coronary artery disease requiring revascularization, congenital bicuspid aortic disease, left ventricular ejection fraction <20%, confirmed stroke within 90 days before the procedure, significant renal insufficiency (defined as creatinine levels >3.0 mg/dl), and/or renal replacement therapy, bacterial endocarditis within 6 months before the procedure, and severe mitral regurgitation.
Valve and delivery system
The study THV (sizes 23 mm, 26 mm, and 29 mm) features a contour-shaped, self-expanding nitinol valve frame with bovine pericardial tissue leaflets (13). The bovine pericardium preparation incorporates a proprietary tissue treatment that allows dry tissue storage and a <5-min automated valve preparation using heparinized saline. The THV is pre-attached to the delivery system and advanced to the native aortic valve via transfemoral access using an expandable 14-F introducer sheath. The delivery system features a steerable delivery catheter to traverse the aortic arch and for coaxial alignment within the annulus, a loading capsule containing the pre-attached THV, and a tapered tip to facilitate valve crossing. A 6-V battery-powered motorized handle enables valve loading and deployment, as well as repositioning with the possibility of recapturing up to 85% of the deployed valve (Online Video 1).
Primary and secondary outcomes
The primary outcome of the study was all-cause mortality at 30 days post-procedure. Secondary endpoints included device success, safety endpoints, clinical functional efficacy, and echocardiographic outcomes according to the Valve Academic Research Consortium 2 (14). Device success was defined as a composite of absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomic location, and intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mm Hg or peak velocity <3 m/s, with no moderate or severe prosthetic valve regurgitation) per echocardiographic assessment at 30 days.
At 30 days, safety endpoints included cardiac mortality, stroke, life-threatening and major bleeding complications, major vascular complications, myocardial infarction, new conduction abnormalities requiring a PPM, acute kidney injury, and new-onset atrial fibrillation.
Clinical functional efficacy included NYHA functional class, 6-min walk distance (6MWD), EuroQol 5 dimensions questionnaire (EQ5D) quality-of-life assessment, hospital length of stay, and rehospitalization.
Echocardiographic hemodynamic assessments evaluated total and paravalvular aortic regurgitation, AVA, mean aortic transvalvular gradient, structural valve deterioration requiring repeat TAVR or SAVR, prosthetic valve dysfunction evidenced by mean aortic valve gradient ≥20 mm Hg, AVA ≤0.9 to 1.1 cm2, and/or Doppler velocity index <0.35 and/or moderate or severe PVL, and left ventricular ejection fraction.
Following discharge from the hospital, clinical follow-up was scheduled at 30 ± 7 days post-procedure. Patients underwent echocardiographic measurements, electrocardiogram recordings, and a global clinical status evaluation. Echocardiographic data was reviewed and evaluated by an independent core laboratory. An independent clinical events committee reviewed and adjudicated all key clinical events according to Valve Academic Research Consortium 2 criteria (14).
Data collection and statistical analysis
All data were entered in the electronic data capture system by the participating centers and monitored by the sponsor. Baseline data were collected for all enrolled patients. The as-treated patient population was defined as consisting of those patients for whom the study valve implantation procedure was begun, and the valve implant (VI) population consisted of all patients who received an implant and retained the valve on leaving the procedure room. Continuous variables are presented as mean ± SD or as median (interquartile range). Categorical variables are presented as percentages of patients. Freedom from events was calculated and presented as event rates. NYHA functional class and echocardiographic data were summarized at baseline, discharge, and at 30 days. The Wilcoxon signed-rank test was used to compare NYHA functional class and paravalvular regurgitation at baseline to values at 30 days. Mean gradients, effective orifice area, EQ5D, and 6MWD were analyzed with a paired Student’s t-test for patients who had data available at both baseline and 30 days. An alpha level of 0.05 was used for all hypothesis testing. All statistical analysis was performed using SAS software version 9.3 (SAS Institute Inc., Cary, North Carolina).
Demographic and baseline characteristics
A summary of patient demographic and baseline data is presented in Table 1. The mean age of the as-treated cohort was 82.7 ± 5.5 years, with 67.5% of patients being female. The primary cardiovascular conditions were hypertension (88.7%), dyslipidemia (55.7%), coronary artery disease (39.4%), previous percutaneous coronary intervention (28.1%), and previous pacemaker implantation (7.4%). The primary noncardiovascular conditions included diabetes (25.6%), renal failure (33.5%), and pulmonary conditions (severe pulmonary hypertension, severe right ventricular dysfunction, and chronic lung disease; 16.3%). At baseline, the mean Society of Thoracic Surgeons score was 6.1 ± 4.2% and the logistic EuroSCORE was 17.1 ± 9.84%, reflecting the heart team decisions for inclusion of these patients. The symptomatic status was classified as NYHA functional class III/IV in 68.0% of the patients. The baseline mean effective orifice area was 0.71 ± 0.20 cm2, the mean transvalvular gradient was 40.6 ± 13.23 mm Hg, and the mean left ventricular ejection fraction was 54.7 ± 9.97%.
The index procedure was started in 203 patients and the THV was successfully implanted by transfemoral access in 198 patients (97.5%). Procedural characteristics are listed in Table 2. The THV was not successfully implanted in 5 patients: in 1 patient because of excessive vascular access calcification and bleeding with subsequent implantation of an Edwards Sapien 3 THV; and in 1 patient because of a guidewire-related cardiac tamponade. Both of these complications resulted in death and a THV was not implanted in either patient. In the remaining 3 patients, the THV was not successfully placed due to valve embolization into the left ventricle in 1 patient and valve migration in 1 patient, with conversion to SAVR in both cases, as well as poor coaxiality in 1 case with subsequent implantation of a Sapien 3 THV. Thus, these 3 patients did not retain the study THV.
Cardiac CT annular perimeter sizing was performed at the discretion of the site with baseline guidance of optimal oversizing in the 10% to 20% range. Based on the cardiac CT core laboratory results, the actual mean annular oversizing for this study was 16.2 ± 5.6%. The recommended CT sizing chart for the THV can be found in Online Figure 1. The choice of the valve size was at the investigator’s discretion. The device selection was largely site based with focus on CT annular perimeter oversizing.
In the VI population (n = 198), 59.1% of patients underwent implantation of a 26-mm valve; the remainder received the 23-mm valve (11.1%) or the 29-mm valve (29.8%). Pre-dilation valvuloplasty was performed in all cases according to the protocol. Post-dilation was performed in 67 patients (33.0%), with a single post-dilation in 90.8% and 2 or more inflations in 9.2% of patients. Only 1 THV was used in each patient. The average duration of the procedure (skin-to-skin) was 67.0 ± 33.4 min, and the mean total fluoroscopy time was 17.9 ± 9.6 min. The contrast medium volume was 147.3 ± 61.6 ml. The majority of patients (85.7%) completed the procedure under conscious sedation. General anesthesia was implemented in 11.8% of patients. Conversion from conscious sedation to general anesthesia due to intraprocedural events was required in 2.5% of patients.
THV recapture and repositioning was required in 3.5% of cases, and none of these maneuvers resulted in ventricular or aortic injury. Cardiopulmonary bypass and intra-aortic balloon pump were used in 2.0% and 0.5% of patients, respectively.
Outcomes at 30 days
The reported numbers and percentages relate to the as-treated population, unless stated otherwise. Follow-up was completed in all patients (100%) at 30 days and no patient was lost to follow-up. The primary endpoint event rate for all-cause mortality at 30 days was 1.0% with the causes of mortality being cardiovascular-related. The observed to expected mortality ratio was 0.16.
Device success at 30 days was 96.4%. The cumulative event rates for any stroke and for disabling stroke were 4.0% and 2.5%, respectively. Cumulative event rates for myocardial infarction were 1.5%, for life-threatening bleeding 4.9%, for major bleeding 14.4%, for acute kidney injury 3.5% (stage 1 = 2.5%; stage 2 = 0.5%; stage 3 = 0.5%), and 0.5% for valve embolization. New-onset atrial fibrillation occurred in 8.0% of patients (16 of 203). Conduction abnormalities for the VI population were reported as atrioventricular block (AVB) grade III in 7.1% of patients (14 of 198) and left bundle branch block in 11.6% (23 of 198). A new PPM was implanted in 4.5% of patients (9 of 198; 4.9% for patients at risk): in 7 cases (3.5%) for AVB grade III, in 1 case due to sick sinus syndrome, and in 1 patient due to atrial fibrillation with slow ventricular response. In 7 patients, AVB grade III was adjudicated as a transient event, of which 6 occurred immediately following the procedure and 1 occurred 24 h subsequent to TAVR. In all patients with new left bundle branch block, PPM implantation was not considered clinically indicated. The decision of PPM implantation was left to the discretion of the operator. Clinical outcomes are shown in Table 3.
The proportion of patients with NYHA functional class III/IV significantly decreased (p < 0.001) from 68.2% at baseline to 7.0% at 30 days after the procedure. Significant improvements in quality of life, as documented by both the EQ5D visual analogue scale and 6MWD, were observed. The EQ5D visual analogue scale at 30 days was 68.0 ± 16.96 (n = 161), which changed from the baseline results of 61.9 ± 16.33 (n = 193). A paired analysis in 158 patients with data available at both time points found an improvement of 6.0 (p < 0.0001). The 6MWD at 30 days was 246.1 ± 160.3 m (n = 151), which changed from the baseline results of 228.4 ± 124.4 m (n = 165). A paired analysis in 133 patients with data available at both time points found an increase of 27.5 m (p = 0.007) (Figure 2).
Echo core laboratory evaluation documented a significant decrease in mean transaortic gradients from 40.5 ± 13.23 mm Hg at baseline to 7.2 ± 2.81 mm Hg at 30 days (p < 0.001). Effective orifice areas significantly increased from 0.71 ± 0.199 cm2 at baseline to 1.88 ± 0.427 cm2 at 30 days (p < 0.001) (Figure 3).
At 30 days, total aortic regurgitation severity was classified as none/trace in 61.8%, mild in 37.6%, and moderate in 0.6% of patients. PVL was assessed as none/trace in 61.9%, mild in 37.5%, and moderate in 0.6% of patients. None of the patients experienced severe aortic regurgitation or a significant PVL (Central Illustration).
This prospective multicenter trial evaluating the self-expanding CENTERA THV presented a safe and effective profile of this new TAVR system for treatment of severe aortic stenosis in a high–surgical-risk patient group. The data indicate that this self-expanding THV is associated with a stable deployment mechanism, high device success, and a low need for recapture and repositioning. Significant improvements in hemodynamic and clinical functional assessments were shown. In comparison with other commercially available SE TAVR systems, the low rate of new PPM implantation and the low incidence of more than mild PVL are notable.
BE THV systems are associated with excellent safety and efficacy (15,16). Thus, the Edwards Sapien 3 THV system has been shown to result in low rates of PVL, low mortalities at 30 days and 1 year, and favorable hemodynamic performance. These beneficial characteristics can be attributed, at least in part, to the high radial force, the low stent frame height, the recently introduced outer skirt, and the large experience (16,17). Conversely, BE valves feature some limitations particularly in small aortic annuli with borderline annular geometry and extensive subannular calcification. In these anatomic subsets, BE THV may be associated with an increased risk of prosthesis-patient mismatch, as well as rupture of the aortic annulus and/or surrounding cardiac structures (18–21). These adverse outcomes may be mitigated by the use of SE THV with the possibility of recapturing and repositioning.
The SE CENTERA valve may also overcome some limitations associated with established SE THV. The all-cause mortality rate was rather low in this patient cohort, with 2 intraprocedural deaths. In both of these cases, the THV was not implanted, due to access site bleeding in 1 case and cardiac tamponade in the other case.
The device success of 96.4% is within the range of other nitinol-based THV, attesting to the robust control and deployment mechanism (12,22–24). Furthermore, a pre-attached valve, without the need for special loading procedures, may facilitate the implantation procedure and reduce possible mishandling with subsequent adverse outcomes. Intraprocedural complications were rare: device embolization/migration occurred in 2 patients and SAVR was performed; the THV was removed before deployment due to poor coaxial orientation and an Edwards Sapien 3 THV was implanted in 1 patient. Periprocedural adverse event rates were low, including disabling stroke (2.5%), life-threatening bleeding (4.9%), vascular complications (6.4%), myocardial infarction (1.5%), and acute kidney injury stage 2 or 3 (1.0%), and are in accordance with other SE nitinol-based THV (12,20–22). The steerability of the THV enables a minimal touch technique with surrounding structures and/or calcifications, which is reflected by the low overall stroke rate. Comparable numbers of 4.9% to 5.5% are reported for 30-day stroke rates of the benchmark valves (4,6).
Transthoracic echocardiography assessment revealed favorable performance parameters of the SE THV studied here at 30 days, in terms of a mean transprosthetic pressure gradient of 7.2 mm Hg and moderate or higher PVL in 0.6% of patients. These results compare favorably with other SE THV. Across the commercially available SE TAVR systems, mean transprosthetic gradients vary between 7.7 and 11.5 mm Hg, and rates of moderate or higher PVL between 1.0% and 13.1% are reported (4,22–24).
In the VI population, the PPM rate of 4.5% (4.9% for patients at risk) is exceptionally low compared with other SE valve platforms, which have reported PPM rates between 11.7% and 26.3% (12,22), but also compared with BE valves with PPM rates between 6.5% and 12% (16,25). Potential explanations for the low observed PPM rate may be related to the low frame height of 18 to 23 mm (frame height of the CoreValve/Evolut R [Medtronic, Minneapolis, Minnesota]: 52 to 55 mm/45 mm; Portico [St. Jude Medical, St. Paul, Minnesota]: 49 to 53 mm) and the minimal protrusion into the left ventricular outflow tract. Importantly, post-interventional left bundle branch block occurred in 23 patients in whom PPM implantation was not considered to be necessary. In 14 patients where AVB grade III was seen, only 7 patients received a PPM implantation, and the other 7 conduction abnormalities were adjudicated as transient events. Therefore, the low PPM rate should be interpreted with care and has to be confirmed in larger patient series.
This clinical investigation lacked a randomized comparator arm and the initial follow-up was limited to 30 days. In addition, the sample size of the study, even though relatively high for other CE mark studies, is still limited. Another limitation is the low patient enrollment in some centers (Online Table 1).
The SE transcatheter CENTERA valve demonstrates stable deployment, high device success, and a low need for recapture and repositioning. The results show adequate early clinical safety and performance outcomes in this high–surgical-risk patient cohort. The rates of mortality, stroke, PPM implantation, vascular complications, and paravalvular regurgitation are low and have to be confirmed with longer follow-up periods and in larger patient groups.
COMPETENCY IN PATIENT CARE AND PROCEDURAL SKILLS: The self-expanding transcatheter valve was associated with satisfactory outcomes at 30 days, with low rates of all-cause mortality, permanent pacemaker implantation or paravalvular regurgitation, in patients with severe, symptomatic aortic stenosis at high surgical risk.
TRANSLATIONAL OUTLOOK: Longer-term, comparative studies are needed to identify clinical characteristics of patients who gain the most benefit from the use of this type of device.
The authors would like to acknowledge the clinical events committee members and the sponsor and give special thanks to all the implanters and the implanting centers. The authors would also like to thank Prof. Philipp Blanke (St. Paul’s Hospital Cardiac CT Corelab) and Prof. Neil Weissman (MedStar Health Research Institute) for their support in conducting this study.
The CENTERA THV trial is sponsored by Edwards Lifesciences. Dr. Reichenspurner has received speaker support and travel honoraria from Edwards Lifesciences; and has served as a consultant to HeartWare/Medtronic. Dr. Schaefer has received travel compensation from Symetis and Abbott Vascular. Dr. Schäfer has received research funding, travel support, and speaker honoraria from Edwards Lifesciences; and has served as a proctor for Edwards Lifesciences. Dr. Tchétché has served as a consultant for Edwards Lifesciences. Dr. Linke has stock options with Claret Medical; has received grant support from Medtronic, Edwards Lifesciences, and Boston Scientific; and has served as a consultant to Abbott Vascular. Dr. Spence has received research funding, travel support, and speaker honoraria from Edwards Lifesciences; and has served as a proctor for Edwards Lifesciences, Boston Scientific, and Medtronic. Dr. Søndergaard has served as a proctor for and received institutional grants from Edwards Lifesciences. Dr. Schymik has served as a proctor for and has received speaker honoraria from Edwards Lifesciences. Dr. Abdel-Wahab has served as a proctor for Boston Scientific; has received institutional research grants from St. Jude Medical and Biotronik; and has received speaker honoraria from Edwards Lifesciences and Medtronic. Dr. Leipsic has served as a consultant to Edwards Lifesciences and Circle Cardiovascular Imaging, and Heartflow; has received institutional support through core laboratory contracts with Edwards Lifesciences, Medtronic, Neovasc, Tendyne, and Ancora; and has stock options in Circle Cardiovascular Imaging and Heartflow. Dr. Walters has served as a proctor for and has performed clinical research for Edwards Lifesciences. Dr. Worthley has received honoraria/consulting fees from Medtronic, St. Jude Medical, and Abbott Vascular. Dr. Kasel has served as a proctor for Edwards Lifesciences and Medtronic. Dr. Windecker has received research grants to the institution from Bracco Pharmaceutical, Boston Scientific, St. Jude Medical, and Terumo. Dr. LeBreton has reported that he has no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- 6-min walk distance
- aortic valve area
- atrioventricular block
- balloon expandable
- computed tomography
- EuroQol 5 dimensions questionnaire (Quality of Life Assessment)
- New York Heart Association
- permanent pacemaker
- paravalvular leakage
- surgical aortic valve replacement
- transcatheter aortic valve replacement
- transcatheter heart valve
- valve implant
- Received July 31, 2017.
- Revision received October 15, 2017.
- Accepted October 17, 2017.
- 2017 American College of Cardiology Foundation
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