Author + information
- Received November 28, 2017
- Revision received February 20, 2018
- Accepted February 22, 2018
- Published online June 18, 2018.
- Suzanne J. Baron, MD, MSc∗ (, )
- Vinod H. Thourani, MD,
- Susheel Kodali, MD,
- Suzanne V. Arnold, MD, MHA,
- Kaijun Wang, PhD,
- Elizabeth A. Magnuson, ScD,
- Augusto D. Pichard, MD,
- Vasilis Babaliaros, MD,
- Isaac George, MD,
- D. Craig Miller, MD,
- E. Murat Tuzcu, MD,
- Kevin Greason, MD,
- Howard C. Herrmann, MD,
- Craig R. Smith, MD,
- Martin B. Leon, MD,
- David J. Cohen, MD, MSc,
- on behalf of the PARTNER 2 Investigators
- ↵∗Address for correspondence:
Dr. Suzanne J. Baron, Saint Luke’s Mid America Heart Institute, University of Missouri–Kansas City School of Medicine, 20 NE Saint Luke’s Boulevard, Suite 240, Lees Summit, Missouri 64086.
Objectives The aim of this study was to evaluate whether transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve (S3-TAVR) results in improved quality of life (QoL) compared with previous-generation TAVR devices or surgical aortic valve replacement (SAVR).
Background In patients with severe aortic stenosis at intermediate surgical risk, TAVR using the SAPIEN XT valve (XT-TAVR) results in similar QoL compared with SAVR. Compared with SAPIEN XT, the SAPIEN 3 valve offers a lower delivery profile and modifications to reduce paravalvular regurgitation.
Methods Between February and December 2014, 1,078 patients at intermediate surgical risk with severe aortic stenosis were treated with S3-TAVR in the PARTNER S3i (Placement of Aortic Transcatheter Valve) trial. QoL was assessed at baseline, 1 month, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short Form-36, and EQ-5D. QoL outcomes of S3-TAVR patients were compared with those in the SAVR and XT-TAVR arms of the PARTNER 2A trial using propensity score stratification to adjust for differences between the treatment groups.
Results Over 1 year, S3-TAVR was associated with substantial improvements in QoL compared with baseline. At 1 month, S3-TAVR was associated with better QoL than either SAVR or XT-TAVR (adjusted differences in Kansas City Cardiomyopathy Questionnaire overall summary score 15.6 and 3.7 points, respectively; p < 0.001). At 1 year, the differences in QoL between S3-TAVR and both SAVR and XT-TAVR were reduced but remained statistically significant (adjusted differences 2.0 and 2.2 points, respectively; p < 0.05). Similar results were seen for generic QoL outcomes.
Conclusions Among patients at intermediate surgical risk with severe aortic stenosis, S3-TAVR resulted in improved QoL at both 1 month and 1 year compared with both XT-TAVR and SAVR.
Over the past decade, multiple trials have demonstrated that transcatheter aortic valve replacement (TAVR) is associated with comparable survival and quality-of-life outcomes compared with surgical aortic valve replacement (SAVR) in patients with severe, symptomatic aortic stenosis (AS) at high surgical risk (1–4). As TAVR has been embraced by the cardiology community, the use of these devices has expanded to lower risk patients with promising results. Recently, the PARTNER 2A (Placement of Aortic Transcatheter Valve) trial demonstrated similar rates of death or disabling stroke as well as similar quality of life at 2 years in patients at intermediate surgical risk treated with either SAVR or TAVR using the second-generation SAPIEN XT valve (Edwards Lifesciences, Irvine, California) (XT-TAVR) (5,6).
While the PARTNER 2A trial was under way, a third-generation balloon-expandable TAVR system, SAPIEN 3 (Edwards Lifesciences), was developed. Compared with SAPIEN XT, SAPIEN 3 offers a lower profile delivery system as well as an outer skirt, designed to reduce paravalvular regurgitation. When TAVR using the SAPIEN 3 valve (S3-TAVR) was compared with SAVR in a propensity-adjusted analysis of intermediate-risk patients, S3-TAVR was found to be associated with reduced rates of death and stroke at 1 year (7). However, many elderly patients who are candidates for TAVR care at least as much about quality of life as they do about duration of life (8). As such, it is important to understand whether differences in clinical outcomes as well as differences in procedure-related complications (such as paravalvular regurgitation, bleeding, atrial fibrillation, or permanent pacemaker implantation) might lead to differences in health status between alternative valve replacement procedures. To address this gap in knowledge, we used data from the PARTNER 2A randomized trial and SAPIEN 3 intermediate-risk registry (PARTNER S3i) to compare health status outcomes among patients with severe AS at intermediate surgical risk treated with S3-TAVR versus either SAVR or XT-TAVR.
Study design and population
The design of the PARTNER 2A randomized trial and the SAPIEN 3 intermediate-risk registry, including inclusion and exclusion criteria (which were identical for the 2 trials), study procedures, and follow-up protocols, has been described previously (5,7). Briefly, these studies enrolled patients with severe, symptomatic AS at intermediate surgical risk (defined as a predicted risk for 30-day mortality between 4% and 8%, on the basis of either the Society of Thoracic Surgeons [STS] mortality risk score or clinical assessment by a multidisciplinary heart team). In the PARTNER 2A trial, patients were stratified according to available access route (transfemoral vs. transthoracic) and randomized 1:1 to undergo either XT-TAVR or SAVR. In PARTNER S3i, patients underwent S3-TAVR via either a transfemoral or a transthoracic approach, as appropriate. Both the PARTNER 2A trial and PARTNER S3i registry were approved by the Institutional Review Board at each site, and written informed consent was obtained from all patients.
Measurement of health status
Health status was evaluated at baseline, 1 month, and 12 months. Both disease-specific and generic health status measures were used, because disease-specific instruments allow a more sensitive assessment of changes in health status in a particular patient population. Disease-specific health status was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ capture 5 key domains of health status in patients with heart failure (physical function, social function, symptoms, self-efficacy and knowledge, and quality of life [defined as the discrepancy between a desired state of health and actual state of health]) and is scored from 0 to 100, with higher scores indicating better health status (9). The individual scales of the KCCQ may be converted into a single overall summary score (KCCQ-OS), which has been shown to correlate with important clinical outcomes including hospitalization, health care costs, and death in heart failure populations (10,11). Among patients with heart failure, small, moderate, and large clinical improvements correspond to changes in the KCCQ-OS of approximately 5, 10, and 20 points, respectively (12). Work by our group has demonstrated the reliability and validity of this instrument for patients with AS (13).
Generic health status was evaluated using the Medical Outcomes Study Short Form-36 (SF-36) questionnaire and the EQ-5D. The SF-36 assesses 8 dimensions of health status and has been validated in patients with cardiovascular disease as well as in the general population (14–16). The SF-36 also provides physical and mental component summary scales, which are scored such that the U.S. population mean is 50 with a standard deviation of 10, with higher scores representing better health status. Minimum clinically important differences on the SF-36 summary scales have been determined to be ∼2 points (17).
The EQ-5D is a multiple-attribute health status classification system that assesses 5 dimensions of general health using a 3-level scale. For the purposes of the PARTNER 2 randomized trial and its associated registries, these responses were transformed into preference-based utility weights using validated population sampling methods (18). These utilities range from 0 to 1, with 0 representing death and 1 representing ideal health.
The primary analytic cohort included only patients who underwent the assigned treatment. Baseline characteristics were compared between cohorts using Student t tests for continuous variables and chi-square tests for categorical variables. Within the S3-TAVR population, health status scores at 1 and 12 months were compared with baseline using paired t tests. Of note, the baseline comparator at each time point consisted of only patients who underwent health status assessments at that time point; as such, these paired comparisons are less susceptible to survivor bias caused by attrition of sicker patients over time.
Although the inclusion and exclusion criteria were identical for the PARTNER 2A trial and the PARTNER S3i registry, there were minor differences in the clinical characteristics of the 2 cohorts. As such, we used propensity score methodology to adjust for baseline differences between treatment groups (19). First, a logistic regression model was developed using 22 pre-specified baseline characteristics to calculate the propensity score for each patient. The STS mortality risk score was not included in this propensity score, as this score is regularly re-estimated by the STS and therefore changes over time. Instead, we included many of the factors that constitute the STS risk score to directly adjust for differences in these variables. We also did not include access site in the propensity score or stratify the analysis by access site. This was necessary because access site is inherent to the specific procedure (i.e., more patients are eligible for transfemoral access with S3-TAVR vs. XT-TAVR because of differences in the diameter of the device delivery system); as such, it would have been inappropriate to include this covariate in our risk adjustment model. A similar logistic regression model was developed for the S3-TAVR versus XT-TAVR comparison. Patients were then partitioned into quintiles on the basis of their propensity scores, and variable balance was evaluated within each quintile to assess the adequacy of the propensity model. The propensity score methodology and model used in this analysis was identical to that used previously to compare clinical outcomes between S3-TAVR and SAVR (7) and to support U.S. Food and Drug Administration approval of the SAPIEN 3 valve. Health status scores at each time point were then compared between the cohorts using analysis of covariance with adjustment for baseline health status and stratification by propensity score quintile.
To provide context for these comparisons, categorical analyses using previously described endpoints that incorporate both health status and survival (20,21) were also performed. A favorable outcome was defined as being alive with a KCCQ-OS score of >60 (roughly equivalent to New York Heart Association functional class II) without a 10-point or greater decrease from baseline. An excellent outcome was defined as being alive with a KCCQ-OS score of >75 (roughly equivalent to New York Heart Association functional class I) without a 10-point or greater decrease from baseline. The association between valve type and these binary outcomes was compared using propensity quintile-stratified logistic regression. Rates of substantial improvement (defined as a >20-point increase in KCCQ-OS score) and moderate improvement (defined as a >10-point increase in KCCQ-OS score) among surviving patients were also compared between treatment groups using a similar approach. Pre-procedural variables associated with favorable outcomes at 1 year in the S3-TAVR population were identified using a multivariate logistic regression model with backward stepwise selection (p < 0.10 for retention).
Finally, we performed informal mediation analyses to explore whether differences in complications between the groups might explain any observed differences in health status. For these analyses, we first performed univariate analyses to identify procedure-related complications associated with impaired 1-year health status. Complications that were considered included disabling stroke, disabling or life-threatening bleeding, major vascular complications, acute kidney injury, new atrial fibrillation, new pacemaker implantation, and moderate or severe aortic regurgitation. Variables that were identified as significant correlates of 1-year health status were then added to the original propensity-adjusted models (along with age, sex, and STS risk score) to assess whether the observed treatment effect was attenuated.
All statistical analyses were performed using SAS version 9.3 (SAS Institute, Cary, North Carolina). A 2-sided p value of <0.05 was considered to indicate statistical significance, with no correction for multiple comparisons.
The PARTNER 2A trial randomized 1,011 patients to undergo XT-TAVR and 1,021 patients to undergo SAVR. Of these patients, 996 underwent XT-TAVR and 944 underwent SAVR. A total of 1,078 patients were enrolled in the PARTNER S3i registry, of whom 1,077 underwent the assigned procedure. Baseline health status was available for 2,829 patients (XT-TAVR, n = 926; SAVR, n = 854; S3-TAVR, n = 1049), which formed our primary analytic cohort.
Baseline characteristics are shown in Tables 1 and 2⇓⇓. Overall, the patients were elderly (mean age 81 years), and 55% to 60% were men. Up to 18% of patients had histories of myocardial infarction, between 24% and 28% had undergone prior coronary artery bypass surgery, and ∼30% had chronic lung disease. After propensity score stratification, the treatment groups were similar, although several patient characteristics remained slightly imbalanced between the groups. This imbalance likely reflects characteristics that were defined differently between the 2 studies (e.g., STS risk score, eligibility for transfemoral access) and were therefore excluded from the propensity model. As expected given the different iliofemoral sizing requirements of the SAPIEN XT and SAPIEN 3 devices, there was a higher rate of transfemoral access eligibility in the S3-TAVR group (88.2% vs. 76.9% for XT-TAVR and 76.8% for SAVR, p < 0.001).
All 3 groups had evidence of significantly impaired health status at baseline (Tables 1 and 2), with mean KCCQ-OS scores of ∼53, which corresponds to New York Heart Association functional class III symptoms. The mean SF-36 physical summary score was ∼36 for all groups, which is ∼1.5 standard deviations below the population mean, and the mean SF-36 mental summary score was ∼48. There were no significant differences in baseline health status among the 3 groups either before or after propensity stratification.
Health status data were available for 97.3% and 95.4% of patients at 1 month and 1 year, respectively, in the S3-TAVR group; for 95.4% and 92.1% at 1 month and 1 year, respectively, in the XT-TAVR group; and for 87.8% and 85.4% at 1 month and 1 year, respectively, in the SAVR group (Online Table A). Baseline characteristics were generally similar for patients with and without 1-year health status data (Online Table B).
Compared with baseline, patients treated with S3-TAVR demonstrated substantial improvements in health status at both 1 month and 1 year follow-up (Table 3). At 1 month, S3-TAVR patients experienced an increase of 19.1 points in KCCQ-OS score from baseline (p < 0.001), and this improvement was sustained at 1 year (mean change from baseline 23.1 points, p < 0.001). Significant health status benefits were also seen on the SF-36 physical summary scale and mental summary scale with 1-year improvements of 5.1 points and 3.9 points, respectively (p < 0.001 for both comparisons).
In propensity-stratified analyses comparing S3-TAVR versus SAVR, there was significantly greater health status improvement at 1 month across all KCCQ scales (mean adjusted difference in KCCQ-OS score 14.6 points; 95% confidence interval [CI]: 13.7 to 17.5; p < 0.001) (Figures 1A and 2A). Similar early benefits of S3-TAVR versus SAVR were seen in the SF-36 physical summary scale (mean adjusted difference 4.7 points; 95% CI: 3.9 to 5.4; p < 0.001) and the SF-36 mental summary scale (mean adjusted difference 6.0 points; 95% CI: 5.0 to 7.0; p < 0.001) (Figure 2B). At 1 year, there remained a significant health status benefit with S3-TAVR versus SAVR as measured by the KCCQ-OS score (mean adjusted difference 2.0 points; 95% CI: 0.1 to 3.8; p = 0.039), but there were no significant differences between S3-TAVR and SAVR for the generic health status instruments (Online Table C).
When S3-TAVR was compared with XT-TAVR, there was evidence of modestly greater health status improvement at 1 month, with a mean adjusted KCCQ-OS score difference of 3.7 points (95% CI: 1.8 to 5.5; p < 0.001) and similar benefits across most of the KCCQ domains (Figures 1B and 3A). Small but significant benefits of S3-TAVR were also seen in the SF-36 physical summary scale (mean adjusted difference 0.8 points; 95% CI: 0.1 to 1.6; p = 0.027) and the SF-36 mental summary scale (mean adjusted difference 1.5 points; 95% CI: 0.6 to 2.5; p = 0.001) (Figure 3B). At 1 year, there remained a significant health status benefit with S3-TAVR on several disease specific scales (mean adjusted KCCQ-OS score difference 2.2 points; 95% CI: 0.4 to 4.0; p = 0.018), but there were no significant differences between S3-TAVR and XT-TAVR for most of the generic health status instruments (Online Table D). Results were virtually identical when missing health status outcomes were imputed using multiple imputation (data not shown).
The results of categorical analyses are summarized in Tables 4 and 5⇓⇓. At 1-month follow-up, the adjusted proportion of surviving patients who experienced substantial (≥20 point) improvement in KCCQ-OS score was significantly greater with S3-TAVR compared with both SAVR (46.6% vs. 26.4%, p < 0.001) and XT-TAVR (46.6% vs. 40.9%, p = 0.015) (Table 4). At 1 year, the benefits of S3-TAVR over both SAVR and XT-TAVR were attenuated but still persisted. Specifically, there remained an absolute 5% difference in the proportion of patients with a substantial improvement in health status, indicating a number needed to treat of ∼20 patients for 1 additional patient to have a substantial improvement in health status with S3-TAVR compared with either SAVR or XT-TAVR. When health status outcomes was combined with survival status, S3-TAVR demonstrated significantly higher adjusted rates of favorable outcomes at 1 year compared with SAVR (75.5% vs. 70.0%; p = 0.018) and with XT-TAVR (75.5% vs. 68.3%; p = 0.001) (Table 5).
Pre-procedural characteristics that were independently associated with a favorable outcome at 1 year after S3-TAVR are shown in Online Table E. Higher baseline KCCQ-OS score was associated with greater likelihood of a favorable 1-year outcome. In contrast, older age, oxygen-dependent chronic obstructive pulmonary disease, diabetes, prior stroke, and poor performance on the 15-foot walk test (e.g., >7 s) were all associated with a reduced likelihood of a favorable outcome at 1 year.
Because the differences in 1-year health status between S3-TAVR and both SAVR and XT-TAVR were somewhat unexpected, we performed additional analyses to assess whether differential rates in periprocedural complications (Online Table F) contributed to the persistent health status benefits seen at 1 year with S3-TAVR. Specifically, among patients treated with S3-TAVR, there were lower rates of disabling or life-threatening bleeding, acute kidney injury, disabling stroke, and new atrial fibrillation compared with both SAVR and XT-TAVR and lower rates of major vascular complications and moderate or severe aortic regurgitation compared with XT-TAVR. When complications were added to the models, the estimated benefits of S3-TAVR versus SAVR and XT-TAVR were attenuated and no longer statistically significant (S3-TAVR vs. SAVR, mean adjusted KCCQ-OS score difference 0.9 points [95% CI: −1.3 to 3.1; p = 0.427]; S3-TAVR vs. XT-TAVR, mean adjusted KCCQ-OS score difference 1.5 points [95% CI: −0.2 to 3.3; p = 0.091]), thus suggesting that the observed differences in long-term health status were driven primarily by differences in peri-procedural complications between the alternative valve replacement strategies.
This is the first study to formally evaluate the effects of a third-generation TAVR device (SAPIEN 3) on health status in patients with severe AS at intermediate surgical risk. In this population, patients treated with S3-TAVR experienced substantial improvement in quality of life within 1 month of treatment, and these benefits were durable through 1 year of follow-up. Furthermore, the health status benefits conferred by S3-TAVR were both substantial and clinically important, with more than 70% of surviving patients demonstrating evidence of at least a moderately large clinical improvement (defined as an increase >10 points in KCCQ-OS score) at 1 year. When S3-TAVR was compared with SAVR in propensity score–adjusted analyses, S3-TAVR was associated with significantly better health status at 1 month. At 1 year, there was evidence of continued, albeit attenuated, benefit of S3-TAVR over SAVR. When S3-TAVR was compared with XT-TAVR, analyses demonstrated a small but significant benefit of S3-TAVR on disease-specific health status at both 1 month and 1 year.
Our findings of significant health status benefit at 1 month with S3-TAVR compared with both SAVR and XT-TAVR are consistent with those of prior studies. The early health status benefit of TAVR over SAVR has been well documented in several trials comparing TAVR and SAVR in patients at both high surgical risk and intermediate surgical risk (1,2,6,22) and reflects the more rapid recovery that would be expected with a less invasive procedure, which does not require a full sternotomy and cardiopulmonary bypass. Although the finding of an early health status benefit of S3-TAVR over XT-TAVR may seem surprising given that both procedures use a similar less invasive approach, the observed difference is likely related to the smaller sheath size required for S3-TAVR, thereby allowing greater use of transfemoral access compared with XT-TAVR. Indeed, prior studies have clearly demonstrated that the early health status benefit seen with TAVR over SAVR is limited to those patients who are treated via a transfemoral approach and that no such advantage is observed in patients treated with a transthoracic approach (1,2,6).
The more unexpected finding of our study was that treatment with S3-TAVR resulted in statistically significant health status improvements not only at 1 month but also at 1 year compared with both SAVR and XT-TAVR. Although these differences were numerically small (∼2 points in KCCQ-OS score for both SAVR and XT-TAVR), these changes may still reflect meaningful changes from a population perspective. Although a 5-point difference in KCCQ-OS score has been shown to be clinically meaningful to an individual patient, it is important to recognize that the mean difference in health status over a population comprises many different individual values. For example, if 40% of patients saw a 5-point improvement in KCCQ-OS score with a specific intervention and 60% of patients saw no improvement, this would still be considered a clinically meaningful improvement by 40% of the individuals in the study but would result only in a 2-point mean difference for the overall study population. Indeed, the 5% absolute difference in the proportion of S3-TAVR patients who experienced a substantial improvement in health status (i.e., a >20-point increase in KCCQ-OS score from baseline) compared with either SAVR or XT-TAVR at 1 year provides direct evidence that the small difference in health status observed at a population level may indeed represent meaningful differences for some patients.
There are several possible explanations for the observed health status benefits of S3-TAVR compared with both SAVR and XT-TAVR at 1 year. First, there were differences in several procedure-related complications between the treatment modalities (e.g., atrial fibrillation, vascular complication, paravalvular leak, stroke), which could have affected health status in the long term. This hypothesis is supported by the results of informal mediation analyses, which demonstrated that when post-procedural complications were included in the model, there was attenuation of the health status benefit seen with S3-TAVR compared with both SAVR and XT-TAVR. These findings suggest that at least part of the 1-year health status benefit seen with S3-TAVR over SAVR and XT-TAVR relates to differing frequencies of post-procedural clinical events. Second, it is possible that the increased use of transfemoral access (which has been associated with improved early recovery after TAVR [2,6]) with S3-TAVR compared with XT-TAVR led to carryover health status benefits in these patients. Ideally, a randomized controlled trial would be needed to confirm the superiority in health status benefits of S3-TAVR over SAVR and XT-TAVR and to fully identify the mechanism by which superiority was achieved.
The results of our study should be interpreted in light of several limitations. First, this was a nonrandomized study, although it is important to note that the PARTNER 2A trial and PARTNER S3i registry used identical inclusion and exclusion criteria, thereby resulting in similar patient characteristics between the studies. In addition, we used a pre-specified propensity score to adjust for differences between the groups. Nevertheless, despite these efforts to reduce confounding, it is possible that the observed differences in health status were driven by differences in patient characteristics that were not controlled for by statistical methods. That said, the results of our mediation analyses suggest that differences in periprocedural complications may explain much of the observed differences in health status between the groups at 1 year, thereby increasing our confidence that the health status differences we observed were in fact due to differences in the treatment modalities and not to patient differences.
Second, quality-of-life assessments were available only through 1 year follow-up. Thus, the durability of these results beyond 1 year is unknown.
Last, these findings apply only to patients with severe AS at intermediate surgical risk with similar baseline characteristics as the study population and should not be generalized to patients who are dissimilar to the analytic cohort.
In patients with severe AS at intermediate surgical risk, S3-TAVR resulted in improved health status at 1 month compared with both SAVR and XT-TAVR. At 1 year, there were also modest improvements in health status observed with S3-TAVR compared with both SAVR and XT-TAVR that appeared to be driven primarily by lower rates of periprocedural complications seen with S3-TAVR. Further studies are needed to evaluate the durability of health status benefits with S3-TAVR in intermediate-risk patients as well as to assess the effects of S3-TAVR in a low-risk surgical population.
WHAT IS KNOWN? The SAPIEN 3 valve is the newest commercially available balloon-expandable TAVR prosthesis and provides several design improvements over earlier generation TAVR prostheses, including a lower delivery profile and an outer skirt aimed at reducing paravalvular regurgitation. Although prior studies have demonstrated that TAVR with the SAPIEN 3 valve is associated with reduced rates of death and stroke compared with SAVR, the effect of SAPIEN 3 on patient-reported outcomes is unknown.
WHAT IS NEW? We found that TAVR with the SAPIEN 3 valve was associated with significant health status benefits at 1 month and 1 year compared with both SAVR and TAVR with the earlier generation SAPIEN XT valve. Mediation analyses suggested that the observed long-term quality-of-life benefits of SAPIEN 3 compared with TAVR using the SAPIEN XT valve or SAVR may be due in part to differences in procedure-related complications associated with the different treatment groups.
WHAT IS NEXT? Further studies are needed to evaluate the durability of health status benefits with SAPIEN 3 in this population.
The PARTNER 2 clinical trial (NCT01314313) and quality-of-life substudy were funded by a research grant from Edwards Lifesciences. Dr. Arnold is supported by a Career Development Grant Award (K23 HL116799) from the National Heart, Lung, and Blood Institute. Dr. Baron has received consulting income from Edwards Lifesciences and St. Jude Medical; and travel reimbursement from Medtronic. Dr. Thourani has received research grants and personal fees from Edwards Lifesciences, Medtronic, St. Jude Medical, Sorin Medical, Boston Scientific, Abbott Vascular and Direct Flow Medical. Dr. Kodali holds equity in Thubrikar Aortic Valve Inc., Dura Biotech, BioTrace Medical, and Microinterventional Devices; has received research grant support from Edwards Lifesciences and St. Jude Medical; is a consultant for Claret Medical, Merrill Lifesciences, BioTrace Medical, Microinterventional Devices; is on the advisory board for Dura Biotech, Abbott Vascular, and Thubrikar Aortic Valve, Inc.; and has received honorarium from Claret Medical, Dura Biotech, and Abbott Vascular. Dr. Pichard has received consulting income from Edwards Lifesciences. Dr. Babaliaros has received research grants and consulting fees from Edwards Lifesciences, Medtronic, St. Jude Medical, Boston Scientific, Direct Flow Medical, and Abbott Vascular. Dr. George has received consulting income from Edwards Lifesciences and Medtronic. Dr. Miller has received consulting income from Abbott Vascular, St. Jude Medical, and Medtronic. Dr. Herrmann has received research grant support from Abbott Vascular, Bayer, Edwards Lifesciences, Boston Scientific, Medtronic, and St. Jude Medical; and consulting income from Edwards Lifesciences. Dr. Cohen has received research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; and consulting income from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- aortic stenosis
- confidence interval
- Kansas City Cardiomyopathy Questionnaire
- Kansas City Cardiomyopathy Questionnaire overall summary
- transcatheter aortic valve replacement using the SAPIEN 3 valve
- surgical aortic valve replacement
- Medical Outcomes Study Short Form-36
- Society of Thoracic Surgeons
- transcatheter aortic valve replacement
- transcatheter aortic valve replacement using the SAPIEN XT valve
- Received November 28, 2017.
- Revision received February 20, 2018.
- Accepted February 22, 2018.
- 2018 American College of Cardiology Foundation
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