Author + information
- Received July 20, 2015
- Revision received August 19, 2015
- Accepted August 19, 2015
- Published online December 21, 2015.
- John G. Webb, MD∗∗ (, )
- Darshan Doshi, MD, MSc†,
- Michael J. Mack, MD‡,
- Raj Makkar, MD§,
- Craig R. Smith, MD†,
- Augusto D. Pichard, MD‖,
- Susheel Kodali, MD†,
- Samir Kapadia, MD¶,
- D. Craig Miller, MD#,
- Vasilis Babaliaros, MD∗∗,
- Vinod Thourani, MD∗∗,
- Howard C. Herrmann, MD††,
- Mark Bodenhamer, MD‡‡,
- Brian K. Whisenant, MD§§,
- Stephen Ramee, MD‖‖,
- Hersh Maniar Jr., MD¶¶,
- Dean Kereiakes, MD##,
- Ke Xu, PhD∗∗∗,
- Wael A. Jaber, MD¶,
- Venu Menon, MD¶,
- E. Murat Tuzcu, MD¶,
- David Wood, MD∗,
- Lars G. Svensson, MD, PhD¶ and
- Martin B. Leon, MD†
- ∗St. Paul’s Hospital, Vancouver, British Columbia, Canada
- †Columbia University Medical Center, New York, New York
- ‡Baylor Scott & White Health, Plano, Texas
- §Cedars Sinai Medical Center, Los Angeles, California
- ‖Medstar Washington Hospital Center, Washington, DC
- ¶Cleveland Clinic, Cleveland, Ohio
- #Stanford University, Stanford, California
- ∗∗Emory University School of Medicine, Atlanta, Georgia
- ††Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
- ‡‡Oklahoma Heart Hospital, Oklahoma City, Oklahoma
- §§Intermountain Medical Center, Salt Lake City, Utah
- ‖‖Ochsner Clinic, New Orleans, Louisiana
- ¶¶Washington University School of Medicine, Saint Louis, Missouri
- ##The Christ Hospital, Cincinnati, Ohio
- ∗∗∗Cardiovascular Research Foundation, New York, New York
- ↵∗Reprint requests and correspondence:
Dr. John G. Webb, St. Paul’s Hospital, 1081 Burrard Street, Vancouver, British Columbia V6Z 1Y6, Canada.
Objectives The purpose of this study was to determine the safety and effectiveness of the SAPIEN XT versus SAPIEN systems (Edwards Lifesciences, Irvine, California) in patients with symptomatic, severe aortic stenosis (AS) who were not candidates for surgery.
Background Transcatheter aortic valve replacement (TAVR) has become the standard of care for inoperable patients with severe, symptomatic AS. In the PARTNER (Placement of Aortic Transcatheter Valves) IB trial, a reduction in all-cause mortality was observed in patients undergoing TAVR with the balloon-expandable SAPIEN transcatheter heart valve compared with standard therapy, but the SAPIEN valve was associated with adverse periprocedural complications, including vascular complications, major bleeding, and paravalvular regurgitation. The newer, low-profile SAPIEN XT system was developed to reduce these adverse events.
Methods A total of 560 patients were enrolled at 28 sites in the United States from April 2011 to February 2012. Patients were randomized to receive the SAPIEN or SAPIEN XT systems. The primary endpoint was a nonhierarchical composite of all-cause mortality, major stroke, and rehospitalization at 1 year in the intention-to-treat population, assessed by noninferiority testing. Pre-specified secondary endpoints included cardiovascular death, New York Heart Association functional class, myocardial infarction, stroke, acute kidney injury, vascular complications, bleeding, 6-min walk distance, and valve performance (by echocardiography).
Results Both overall and major vascular complications were higher at 30 days in patients undergoing TAVR with SAPIEN compared with SAPIEN XT (overall: 22.1% vs. 15.5%; p = 0.04; major: 15.2% vs. 9.5%; p = 0.04). Bleeding requiring blood transfusions was also more frequent with SAPIEN compared with SAPIEN XT (10.6% vs. 5.3%; p = 0.02). At 1-year follow-up, the nonhierarchical composite of all-cause mortality, major stroke, or rehospitalization was similar (37.7% SAPIEN vs. 37.2% SAPIEN XT; noninferiority p value <0.002); no differences in the other major pre-specified endpoints were found.
Conclusions In inoperable patients with severe, symptomatic AS, the lower-profile SAPIEN XT is noninferior to SAPIEN with fewer vascular complications and a lesser need for blood transfusion. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves; NCT01314313)
Transcatheter aortic valve replacement (TAVR) has become the standard of care for patients with severe, symptomatic aortic stenosis (AS) who are at prohibitive surgical risk or who possess unfavorable anatomic features for surgical aortic valve replacement. In the PARTNER (Placement of Aortic Transcatheter Valves) IB trial, a reduction in all-cause mortality was observed over 5 years in patients deemed unsuitable for surgical aortic valve replacement undergoing TAVR with the balloon-expandable SAPIEN transcatheter heart valve (Edwards Lifesciences, Irvine, California) compared with standard therapy (1–4). These findings, as well as those from subsequent trials and large international registries (5–10), have led to a Class I indication for TAVR in the treatment of symptomatic patients with inoperable, severe AS in all major valve guidelines (11,12).
Yet despite the safety and efficacy of the SAPIEN valve, TAVR procedures were still associated with high rates of adverse periprocedural complications, including vascular injury, bleeding, and paravalvular regurgitation (13–15). The next generation, balloon-expandable SAPIEN XT valve and its lower-profile delivery system were designed to reduce many of these adverse events. However, whether these design changes result in improved outcomes with TAVR remains unknown. We therefore performed a randomized evaluation of the SAPIEN XT compared with the SAPIEN valve as part of the PARTNER IIB study to assess the newer, low-profile device in inoperable patients with severe AS.
Patients with severe AS and New York Heart Association (NYHA) functional class ≥II were enrolled into the PARTNER II trial. Severe AS was defined as an aortic valve area ≤0.8 cm2, a mean aortic valve gradient ≥40 mm Hg, a peak aortic jet velocity ≥4.0 m/s, or an indexed aortic valve effective orifice area <0.5 cm2/m2.
The PARTNER II study consisted of 2 parallel, independently powered, randomized controlled multicenter trials (cohorts A and B) and 6 nested registries (NR1 to NR6). Cohort A consisted of operable patients who were considered moderate- or high-risk candidates for surgery, defined by a Society of Thoracic Surgeons (STS) risk score ≥4%. These patients were randomized to TAVR with SAPIEN XT or surgical aortic valve replacement. Cohort B consisted of inoperable patients who had coexisting conditions that would be associated with a predicted probability of ≥50% of either death or serious irreversible morbidity at 30 days after treatment. These patients were randomized to transfemoral TAVR with either SAPIEN or SAPIEN XT. Inoperable patients were enrolled in the nested registries if they lacked appropriate transfemoral access and required transapical or transaortic TAVR (NR1 and NR4, respectively), possessed small femoral vessel diameters of 6 to 7 mm (NR2), required an aortic valve-in-valve implantation for bioprosthetic valve failure (NR3), or required transfemoral or transapical TAVR with a 29-mm prosthesis (NR5 and NR6, respectively). Here we report the results for the inoperable, randomized cohort B patients.
Study device and procedure
The SAPIEN transcatheter heart valve and the SAPIEN XT have been described previously (16). Briefly, the SAPIEN XT consists of bovine pericardium (in a partially closed resting geometry) sewn to a balloon-expandable thinner strut cobalt-chromium alloy tubular frame. Both valves were available in 23- and 26-mm sizes and were implanted with the use of dedicated transfemoral delivery systems. The SAPIEN transcatheter valve was delivered with the RetroFlex 3 catheter, which required the use of 22- or 24-F introducer sheaths. The SAPIEN XT was delivered with the lower-profile NovaFlex catheter, which employed smaller 18- or 19-F introducer sheaths. Patients were selected on the basis of having satisfactory transarterial access for the larger 22- and 24-F delivery systems. Balloon inflation was utilized to expand the frame and secure it to the underlying aortic valve annulus and leaflets.
All patients received aspirin (81 mg) and clopidogrel (≥300 mg) prior to the procedure, received heparin during the procedure, and were maintained on aspirin 81 mg indefinitely. Clopidogrel was continued for a minimum of 1 month. Patients with atrial fibrillation were placed on warfarin within 24 h of the procedure.
Study design and oversight
The PARTNER II study incorporated 2 parallel prospective, multicenter, randomized, active-treatment–controlled clinical trials. The study was designed jointly by the sponsor, Edwards Lifesciences, and the PARTNER executive committee. Patients were randomly assigned with the use of a computer-generated scheme, blocked separately at each participating site and for each of the trial cohorts. An independent clinical events committee adjudicated all serious outcomes utilizing the Valve Academic Research Consortium (VARC) criteria (17). An independent data and safety monitoring board met frequently, had access to all study data and treatment assignments, and recommended after each meeting that the study be continued without modification. The executive committee met in person every 8 to 12 weeks to monitor all other aspects of the conduct of the trial. All data were sent for analysis to independent consulting biostatisticians. Independent core laboratories analyzed all electrocardiograms and echocardiograms. Authors had unrestricted access to all study data after the database was locked, made the decision to submit the manuscript for publication, prepared all drafts of the manuscript, and take responsibility for the integrity of the data and the accuracy of the data analysis.
The primary safety and effectiveness endpoint was a nonhierarchical composite of all-cause mortality, major stroke, or rehospitalization at 1 year in the intention-to-treat population. Pre-specified secondary endpoints included death from cardiovascular causes, NYHA functional class, myocardial infarction, stroke, acute kidney injury, vascular complications, bleeding, 6-min walk distance, and echocardiography-assessed valve performance. In this report, all patients were followed for at least 2 years with annual clinical visits and echocardiographic evaluations.
We estimated that a sample size of 458 patients would yield at least 80% power to demonstrate noninferiority of SAPIEN XT to SAPIEN with regard to the primary endpoint, assuming 1-year composite event rates of 43.6% in both trial arms and a noninferiority ratio of 1.35 at a 1-sided alpha of 0.025. The randomized sample size was set to 500 patients to allow for possible loss to follow-up and other trial contingencies.
Statistical comparisons of the primary and other endpoints between the SAPIEN and SAPIEN XT groups were performed using Mann-Whitney U tests for continuous variables and chi-square or Fisher exact tests for categorical variables. Primary data analysis was performed in the intention-to-treat population, regardless of the treatment that was actually received. Time-to-event analyses were performed with the use of Kaplan-Meier estimates and were compared between groups with the use of the log-rank test. All statistical analyses were performed with the use of SAS software version 9.2 (SAS Institute, Cary, North Carolina).
Patients and enrollment
Between March 2011 and February 2012, 560 patients were enrolled at 28 sites in the United States and were randomly assigned to TAVR with SAPIEN (n = 276) or SAPIEN XT (n = 284). All patients were followed for least 2 years (median follow-up 722.5 days; maximum 1,198 days). The number of patients who underwent randomization and follow-up is shown in Figure 1.
Baseline characteristics of the 2 groups were similar (Table 1). The overall mean STS score (10.6%) demonstrated high operative risk status. However, there were also many patients with low STS scores but with coexisting conditions that contributed to the determination that the patient was not suitable for surgery, including frailty (59.6%), oxygen-dependent respiratory difficulties (14.5%), porcelain aorta (5.4%), chest wall radiation (3.9%), and chest wall deformities (3.6%).
Among the 560 patients, 6 patients (2.2%) in the SAPIEN group and 2 patients (0.7%) in the SAPIEN XT group did not receive a transcatheter valve. The reasons were death prior to the index procedure or withdrawal from the study. During the TAVR procedure or in the first 24 h after the procedure, 7 patients died (4 with SAPIEN and 3 with SAPIEN XT), 7 patients had major strokes (3 with SAPIEN and 4 with SAPIEN XT), and 3 patients had valve embolizations (1 with SAPIEN and 2 with SAPIEN XT).
Several key intraprocedural differences were observed between the 2 groups. The anesthesia time was greater in SAPIEN patients compared with SAPIEN XT (212.0 ± 75.7 min vs. 197.6 ± 60.8 min; p = 0.02). There was also a trend toward longer overall procedure times with SAPIEN (109.3 ± 57.3 min vs. 101.0 ± 43.2 min; p = 0.06), as well as more aborted procedures (3.0% vs. 0.7%; p = 0.06) and more frequent intra-aortic balloon pump use (p = 0.06).
Death, major stroke, and repeat hospitalization
At 30 days after randomization, all-cause mortality was similar (5.1% with SAPIEN and 3.5% with SAPIEN XT; p = 0.36), as were rates of major stroke (3.0% vs. 3.2; p = 0.85) and re-hospitalization (10.6% vs. 11.6%; p = 0.70) (Figure 2). The nonhierarchical composite of all-cause mortality, major stroke, and rehospitalization at 30 days was also similar for SAPIEN and SAPIEN XT patients (15.7% vs. 17.0%; p = 0.68).
At 1-year follow-up, the nonhierarchical composite of all-cause mortality, major stroke, or re-hospitalization (the primary endpoint) was 37.7% in the SAPIEN group compared with 37.2% in the SAPIEN XT group (p = 0.90) (Table 2). The risk ratio of the composite primary endpoint between the SAPIEN XT group and the SAPIEN group was 0.99. On the basis of a pre-specified noninferiority margin of 1.35, the trial’s risk ratio met the criteria for noninferiority (p < 0.002) with a 1-sided alpha of 0.025. Similarly, there were no differences between the SAPIEN and SAPIEN XT groups at 1-year follow-up for all-cause mortality (23.3% vs. 22.3%; p = 0.75), major stroke (5.5% vs. 4.8%; p = 0.76), or rehospitalization (24.1% vs. 23.1%; p = 0.79). At 2-year follow-up, there was still no difference between the composite and individual component endpoints.
Other clinical outcomes
At 30 days, vascular complications were seen more frequently in patients undergoing TAVR with the SAPIEN transcatheter valve compared with SAPIEN XT (22.1% vs. 15.5%, hazard ratio [HR]: 1.45; p = 0.04) (Table 2). In particular, the SAPIEN group experienced substantially more major vascular complications than SAPIEN XT (15.2% vs. 9.5%, HR: 1.61; p = 0.04). Within the subgroup of vascular complications, SAPIEN patients had more frequent perforations than SAPIEN XT patients (4.7% vs. 0.7%, HR: 6.71; p = 0.003). Other vascular complications, such as dissections and hematomas, were also numerically greater in the SAPIEN group compared with SAPIEN XT but failed to meet statistical significance. Periprocedural bleeding requiring blood transfusions was statistically more frequent in the SAPIEN group compared with SAPIEN XT (10.6% vs. 5.3%, HR: 2.02, 95% confidence interval: 1.08 to 3.76; p = 0.02).
At 30 days and 1 year, there was significant improvement in NYHA symptoms compared with baseline, with no differences between the 2 groups. Nearly 85% of all patients had an improvement of at least 1 NYHA functional class at 30 days, and 91% had this improvement by 1 year. At 1 year, patients in both groups experienced improved 6-min walk distance; no significant between-group differences were observed.
Effective aortic valve area and gradients improved substantially with both SAPIEN and SAPIEN XT from baseline to 30 days (Table 3). In the SAPIEN cohort, the mean aortic valve area increased from 0.62 ± 0.17 cm2 at baseline to 1.53 ± 0.40 cm2 post-procedure, and the mean gradient fell from 45.11 ± 14.21 mm Hg to 10.83 ± 5.37 mm Hg. In the SAPIEN XT cohort, the mean aortic valve area increased from 0.63 ± 0.18 cm2 to 1.58 ± 0.43 cm2, and the mean gradient fell from 45.09 ± 13.63 mm Hg to 10.03 ± 3.85 mm Hg. Paravalvular regurgitation was similar both devices at the time of discharge, at 30 days, and at 1-year follow-up. Although the majority of patients were found to have no or mild paravalvular regurgitation, for both groups, approximately 20% of the patients had moderate or severe paravalvular regurgitation at the time of discharge, without important changes at 30-day and 1-year follow-up.
In this randomized, multicenter study of the lower-profile SAPIEN XT valve compared with the original SAPIEN valve in inoperable patients with severe, symptomatic AS, there was no difference at 1 or 2 years in the nonhierarchical composite endpoint of all-cause mortality, major stroke, or rehospitalization, nor with any of the individual endpoints. However, major vascular complications and bleeding requiring transfusions were reduced with SAPIEN XT. Patients undergoing TAVR with SAPIEN XT also required shorter anesthesia time, with trends toward reduced overall procedure time, fewer aborted procedures, and a less frequent need for a second transcatheter heart valve or intra-aortic balloon pump support.
A distinguishing feature of the SAPIEN XT system is its lower profile, and as the present study demonstrates, the reduced size of entry catheters and sheaths resulted in meaningful reductions in both vascular complications. The use of larger-profile devices (>20-F) coupled with a challenging anatomic substrate (older patients with frequent peripheral vascular disease) resulted in 10% to 15% major vascular complications in prior TAVR studies (1,18,19). One of the strongest predictors of major vascular complications after TAVR is a larger sheath-to-femoral artery ratio (20,21), and thus, it was expected that a lower-profile device would result in fewer vascular complications. In the present trial, the lower-profile SAPIEN XT system led to a 6.5% absolute reduction in all forms of vascular complications, a 5.7% absolute reduction in major vascular complications, and a 4% reduction in perforations at 30 days. This reduction in vascular complications has important clinical implications because it has previously been shown that major vascular complications are associated with increased major bleeding, renal failure requiring dialysis, and mortality at both 30 days and 1 year (14).
Several prior studies have established the harmful effects of blood transfusions after a cardiovascular procedure, including an increase in the risk of infection, ischemic events, length of stay, and hospital costs (22–24). In particular, bleeding requiring transfusion after TAVR has been associated with higher 30-day and 1-year mortality and increased risk of major stroke and acute kidney injury (24–26). The use of SAPIEN XT in this trial resulted in a 2-fold reduction in bleeding requiring transfusion at 30 days, which has important implications in improving overall clinical outcomes.
The primary findings of this randomized trial are in direct accordance with previously reported SAPIEN XT registries (27–31). However, the rate of moderate or severe paravalvular regurgitation in the present trial is nearly double the rate reported in other trials or registries of balloon-expandable transcatheter valves. In the PARTNER IB trial, the SAPIEN valve was associated with rates of moderate or severe paravalvular regurgitation of 11.8% at 30 days and 10.5% at 1 year. In contrast, the current study reports higher rates with the same valve of 17.1% at 30 days and 21.1% at 1 year (1). We believe that this difference in the incidence of paravalvular regurgitation using the same model of transcatheter valve and targeting similar patient populations is likely due to differences in the methods used by the echocardiography core laboratories to grade paravalvular regurgitation. The 2 trials utilized different echocardiographic core laboratories with differing methodologies. Unlike the methods used by the PARTNER 1 core laboratory for paravalvular regurgitation assessment, the core laboratory for this trial used the American Society of Echocardiography guidelines with the lower circumferential extent criteria; specifically, paravalvular regurgitation was considered severe when the regurgitant jet was >20% of the short axis annular circumference. Moreover, circumferential extent was weighted more heavily than other parameters by the echocardiographic core laboratory of this trial.
A recent PARTNER IIB analysis demonstrated that when a consortium of echocardiography core laboratory directors re-reviewed 100 randomly chosen echocardiograms from this trial, there was a systemic overestimation of greater than mild paravalvular regurgitation by the PARTNER IIB core laboratory; 15.9% of patients graded by the core laboratory as having moderate paravalvular regurgitation would have been graded as having mild paravalvular regurgitation by the consortium of laboratory directors (32). This finding underscores the difficulty with accurate and consistent assessment of post-TAVR paravalvular regurgitation severity due to the fact that paravalvular regurgitation jets are frequently multiple in number, irregular in shape, and eccentric in direction. Moreover, echocardiographic guidelines, which have been developed for assessing the severity of paravalvular regurgitation for surgical prostheses, have not been well validated for transcatheter valves. These pitfalls could have led to difficulty achieving consistent paravalvular regurgitation assessments between echocardiography core laboratories.
Of note, although the construct of the present trial is similar to the original PARTNER IB trial in many ways, there are important methodological differences. PARTNER IIB applied more rigorous clinical trial methodologies, including utilizing VARC criteria for assessing outcomes to facilitate meaningful comparisons with other clinical trials (17). Moreover, unlike the original PARTNER I trial, the present trial required all enrolled patients to undergo strict neurological assessments before TAVR and at regular, pre-specified intervals afterward. Nevertheless, despite the mandated neurological evaluations, the stroke frequency was not higher, but rather was lower than in PARTNER IB. Major strokes occurred in 5% at 30 days and 7.8% at 1 year in PARTNER IB, whereas the combined major stroke rate for both the SAPIEN and SAPIEN XT valves in the present trial was 3.1% at 30 days and 5.2% at 1 year. The lower stroke rate is not unexpected, as several studies have indicated that the stroke frequency after TAVR has been declining in recent years due to improved case selection, procedural technique refinements, increased operator experience, and new TAVR systems (33).
First, shortly after adjudication of clinical events had begun with this trial, the updated VARC-2 criteria were developed (34). Given that the trial was designed and powered with the original VARC criteria, the decision was made by the executive committee and sponsor to continue adjudication utilizing the original VARC criteria. Second, after enrollment of the PARTNER IIB trial was largely complete, newer and even lower profile 16- and 18-F expandable sheaths (eSheath, Edwards Lifesciences) were developed for the delivery of the SAPIEN XT valves. It is possible that the use of these sheaths in our trial may have resulted in further improvements in vascular and bleeding complications, although a recent study did not demonstrate such an advantage (35). Third, the heart team’s determination of inoperability may have changed compared with the earlier PARTNER IB study due to increased clinical experience with TAVR over time. Last, as previously discussed, this trial employed a different echocardiography core laboratory that, upon re-review, systemically overestimated the severity of paravalvular regurgitation.
The SAPIEN XT is an incremental improvement from the prior generation of TAVR technology with a reduced risk of vascular injury and bleeding events requiring transfusion. The SAPIEN XT should be regarded as the next standard of care for patients undergoing balloon-expandable TAVR.
WHAT IS KNOWN? TAVR with the SAPIEN transcatheter heart valve in inoperable patients with severe AS has been shown to be superior to standard therapy. However, whether the lower-profile SAPIEN XT transcatheter heart valve compares favorably to the original SAPIEN transcatheter valve remains unknown.
WHAT IS NEW? There was no difference in all-cause mortality, major stroke, or rehospitalization between SAPIEN and SAPIEN XT, but the SAPIEN XT was associated with less vascular complications and bleeding requiring transfusion.
WHAT IS NEXT? Evaluation of the even newer SAPIEN 3 transcatheter heart valve compared with the SAPIEN and SAPIEN XT transcatheter valves.
The PARTNER II trial was funded by Edwards Lifesciences. The protocol was designed collaboratively by the sponsor and the executive committee. Data collection and monitoring was managed by the sponsor, but the authors were solely responsible for preparation, review, and approval of the manuscript as well as the decision to submit for publication. Dr. Webb is a consultant for Edwards Lifesciences. Dr. Doshi is supported by National Institutes of Health grant #5T32HL007854-19; and has received research grant funding from Abiomed. Dr. Makkar has received grants from Edwards Lifesciences and St. Jude Medical; is a consultant for Abbott Vascular, Cordis, and Medtronic; and holds equity in Entourage Medical. Dr. Smith receives reimbursement from Edwards Lifesciences for travel and customary expenses related to trial management as surgical principal investigator of the PARTNER trial. Dr. Pichard is a consultant for Edwards Lifesciences. Dr. Kodali is a consultant for Edwards Lifesciences and a member of the Scientific Advisory Board of Thubrikar Aortic Valve. Dr. Miller is supported by National Heart, Lung, and Blood Institute research grant R01 #HL67025; is a consultant for Abbott Vascular, St. Jude Medical, GenTAC, and Medtronic; and has received research/grant support from Medtronic, Edwards Lifesciences, and Abbott Vascular. Dr. Babaliaros has served as a consultant for and investigator with Abbott Vascular and Edwards Lifesciences. Dr. Thourani is a member of the PARTNER Trial Steering Committee and a consultant for Edwards Lifesciences, Sorin Medical, St. Jude Medical, and DirectFlow. Dr. Herrmann has received grants from Edwards Lifesciences, St. Jude Medical, Medtronic, Boston Scientific, Abbott Vascular, Gore, Siemens, Cardiokinetix, and Mitraspan; is a consultant for Edwards Lifesciences and Siemens; and holds equity in Microinterventional Devices. Dr. Whisenant has served on the Speakers Bureau for Edwards Lifesciences. Dr. Ramee has served as a clinical investigator for Edwards Lifesciences; and has received honoraria from Edwards Lifesciences (<$15,000) and Medtronic (<$5,000). Dr. Jaber has a Core Lab Contract (no direct compensation) with Edwards Lifesciences. Dr. Wood has served as a consultant for and received grant support from Edwards Lifesciences. Drs. Mack, Miller, Smith, Tuzcu, and Leon are members of the PARTNER executive committee (no direct compensation). Dr. Svensson has received travel reimbursements from Edwards Lifesciences related to his work as an unpaid member of the PARTNER Trial Executive Committee, holds equity in Cardiosolutions and ValvXchange, and has Intellectual property rights/royalties from Posthorax. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- aortic stenosis
- nested registries
- New York Heart Association
- Society of Thoracic Surgeons
- transcatheter aortic valve replacement
- Valve Academic Research Consortium
- Received July 20, 2015.
- Revision received August 19, 2015.
- Accepted August 19, 2015.
- American College of Cardiology Foundation
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