Abstract
Background
American College of Cardiology/American Heart Association guidelines include a class I indication for surgical aortic valve replacement (SAVR) over transcatheter aortic valve replacement (TAVR) in patients age <65 years. This analysis assessed outcomes of SAVR versus TAVR in patients <65 years.
Methods
This was a retrospective, single-institution study of consecutive SAVRs and TAVRs performed between 2013 and 2023. Patients age <65 years were included, and those who underwent concomitant operations or prior AVR were excluded. To balance the AVR cohorts, propensity score matching (PSM) was performed using a 1:1 match ratio. Short-term clinical and echocardiographic outcomes were compared. Kaplan-Meier survival estimation and Fine-Gray analysis of heart failure readmission were performed to evaluate mid-term outcomes after AVR.
Results
A total of 761 patients age <65 years underwent AVR, including 655 with SAVR and 106 with isolated TAVR. PSM yielded a cohort of 97 SAVR patients and 97 TAVR patients age <65. After matching, the 2 groups were acceptably balanced across all baseline variables. No significant differences were observed in most immediate postoperative complications. Kaplan-Meier survival estimates were significantly lower for those who underwent TAVR, with 5-year survival rates of 46.3% for TAVR versus 79.7% for SAVR (P < .01). The cumulative incidence of heart failure readmissions was significantly higher in the TAVR group, with a 5-year incidence of 43.1% versus 20.8% in matched SAVR patients (P < .01).
Conclusions
TAVR was significantly associated with decreased mid-term survival and increased heart failure readmissions compared to SAVR in patients age <65 years.
Key Words: surgical aortic valve replacement, transcatheter aortic valve replacement, propensity-score matching, under 65, Kaplan-Meier survival, Fine-Gray model
Survival (A) and heart-failure readmissions (B) in matched SAVR patients and TAVR patients age <65 years.
Central Message.
After propensity score matching, TAVR was significantly associated with decreased mid-term survival and increased heart failure readmissions compared to SAVR in patients age <65 years.
Perspective.
While immediate postoperative outcomes are excellent in matched patients undergoing SAVR and TAVR, mid-term outcomes vary. With TAVR being performed at alarmingly high rates in patients age <65, further randomized and propensity score–matched studies are needed before recommending and implementing TAVR in this patient population.
The advent of transcatheter aortic valve replacement (TAVR) has impacted treatment of aortic stenosis (AS), broadly expanding the pool of patients eligible for aortic valve replacement (AVR).1, 2, 3, 4 Recent clinical trials comparing the safety profile of TAVR to surgical aortic valve replacement (SAVR) have shown comparable long-term outcomes in high-risk and intermediate-risk patients, most of whom ranged in age from 70 to 85 yearsf age.5, 6, 7, 8 However, for patients age <65 years, there is a general paucity of randomized control trial data on clinical outcomes after TAVR versus SAVR.9 As a reflection of this current deficiency in TAVR literature, the 2020 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines include a class I indication for SAVR rather than TAVR in patients age <65.10 Nevertheless, recent findings surveying US regional and national cardiac surgery databases show that TAVR is being performed at high rates in this patient age group, with some studies documenting TAVR rates of nearly 50% in patients age <65 who underwent AVR in 2021.11,12
This practice is in direct conflict with guideline-based age recommendations for AVR and may have an impact on lifetime management strategies in younger patients with severe AS. Thus, further investigation of SAVR versus TAVR outcomes in patients age <65 is warranted. Here we present our institutional experience with SAVR and TAVR operations in patients age <65 to compare long-term postoperative morbidities and mortality between the 2 treatment options.
Methods
Patient Population and Study Design
This retrospective, propensity score–matched, observational study was conducted using an institutional database of SAVR and TAVR operations performed at University of Pittsburgh Medical Center between 2013 and 2023. Definitions and terminology were consistent with those used in the Society of Thoracic Surgeons (STS) database and the STS–American College of Cardiology Transcatheter Valve Therapy Registry.13,14 All patients age <65 who underwent isolated SAVR or TAVR were included in the study. Included patients age <65 who underwent TAVR were thoroughly evaluated in the preoperative setting by a multidisciplinary heart team on a case-by-case basis and either were deemed at high risk for SAVR or strongly expressed an individualized preference for a transcatheter approach to AVR.
Although no fixed algorithm was used to consider patients suitable for TAVR, the heart team at our institution consisted of 2 cardiothoracic surgeons and 2 interventional cardiologists who jointly reviewed patient anatomy and holistically assessed patients’ comorbidities and life expectancies. Patients who underwent concomitant operations, aortic root interventions, or had prior AVR procedures were excluded. This study was approved by the Institutional Review Board of the University of Pittsburgh on April 17, 2019 (STUDY18120143), with a waiver of written consent.
This study aimed to compare the clinical and echocardiographic outcomes of patients age <65 who underwent first-time SAVR and those who underwent first-time TAVR. The primary outcome investigated was long-term survival. Additional outcomes of interest included in-hospital postoperative morbidities and echocardiographic evidence of aortic regurgitation and paravalvular leak. For the PSM analysis, missing data were handled via single imputation by group median if <15% of the total cohort was missing. All follow-up data were obtained from a clinical warehouse containing long-term survival data for patients undergoing cardiac operations at the University of Pittsburgh Medical Center.
Statistical Methods
Primary stratification was between the SAVR and TAVR groups. Continuous variables are presented as mean ± standard deviation for normally distributed data and as median and interquartile range (IQR) for nonnormally distributed data. Categorical data are reported as frequency and percentage. Normally distributed continuous variables were analyzed using the Student t test, whereas nonnormally distributed continuous variables were analyzed with the nonparametric Mann-Whitney U test. The normality of continuous variables was assessed using Q-Q plots, followed by the Shapiro-Wilk test. The χ2 or Fisher exact test, as appropriate, was used to compare categorical variables between groups.
The patients were propensity score–matched to compare the SAVR and TAVR treatment modalities. Logistic regression was used to calculate propensity scores based on all baseline demographic, clinical, and operative variables listed in Table 1. The matched cohort was generated via 1:1 nearest-neighbor matching without replacement, using a caliper of 0.2 of the standard deviation of the logit propensity score. After matching, standardized mean differences (SMDs) were calculated to assess covariate balance, with an SMD <0.10 (absolute value) considered well balanced and an SMD <0.15 (absolute value) considered acceptably balanced.
Table 1.
Baseline characteristics in the matched cohorts
| Variable | SAVR (N = 97) | TAVR (N = 97) | SMD |
|---|---|---|---|
| Age, y, mean ± SD | 59.5 ± 4.3 | 60.0 ± 4.4 | 0.08 |
| Female sex, n (%) | 50 (51.6) | 50 (51.6) | 0 |
| BMI, kg/m2, mean ± SD | 32.0 ± 7.7 | 33.2 ± 11.8 | 0.12 |
| Diabetes, n (%) | 46 (47.4) | 46 (47.4) | 0 |
| Cardiovascular disease, n (%) | 16 (16.5) | 21 (21.7) | 0.14 |
| Congestive heart failure, n (%) | 82 (84.5) | 82 (84.5) | 0 |
| Chronic lung disease, n (%) | 47 (48.5) | 46 (47.4) | 0.02 |
| Aortic valve mean gradient, mm Hg, mean ± SD | 48.1 ± 18.9 | 48.5 ± 15.0 | 0.02 |
| Ejection fraction (%) | 52.5 ± 13.4 | 51.8 ± 14.6 | 0.05 |
| STS score, %, median (IQR) | 1.8 (1.0-2.9) | 3.9 (2.1-6.1) | P < .01 |
| STS score ≤4%, n (%) | 79 (81.4) | 51 (52.6) | |
| STS score 4%-8%, n (%) | 12 (12.4) | 28 (28.9) | |
| STS score >8%, n (%) | 6 (6.2) | 18 (18.6) |
SAVR, Surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement; SMD, standardized mean difference; BMI, body mass index; STS, Society of Thoracic Surgeons.
After PSM, survival estimates were generated using Kaplan-Meier methods and compared using log-rank statistics. Finally, Fine-Gray competing-risk cumulative incidence estimates for heart failure readmissions were compared between the 2 groups using Gray K-sample statistics, with death treated as a competing risk. All statistical analyses were performed with SAS/STAT version 15.2 (SAS Institute). All tests were 2-sided, with an level of 0.05 considered to indicate statistical significance.
Results
Baseline Variables
The study cohort comprised 761 patients age <65 who underwent AVR, including 655 patients (86.1%) who underwent SAVR and 106 (13.9%) who underwent TAVR. Baseline characteristics and postoperative clinical outcomes for the total study group are shown in Tables E1 and E2. PSM of the SAVR and TAVR cohorts was performed to balance patient covariates between groups. Table 1 presents baseline data for the matched cohort (n = 194), comparing the SAVR (n = 97) and TAVR (n = 97) groups. After matching, the groups were acceptably balanced across all baseline variables (SMD < 0.15). After matching, whereas TAVR patients had significantly higher preoperative STS risk scores, the median risk score was <4% in both groups.
Procedural and Echocardiographic Outcomes
Table 2 compares postprocedural outcomes across the matched groups. Among the SAVR patients, 46 (47.4%) received a biologic valve. Among the TAVR recipients, 66 (68.7%) received a balloon-expanding valve and 30 (31.3%) were implanted with a self-expanding valve. Hospital length of stay and blood product transfusion were significantly higher in the SAVR group (P < .01); otherwise, postoperative outcomes were similar in the matched age <65 SAVR and TAVR cohorts (P > .05).
Table 2.
Postoperative clinical outcomes in the matched cohorts
| Variable | SAVR (N = 97) | TAVR (N = 97) | P value |
|---|---|---|---|
| Operative characteristics | |||
| Aortic implant size, mm, mean ± SD | 23.7 ± 2.4 | 26.8 ± 2.6 | <.01 |
| Valve type, n (%) | |||
| Biologic valve | 46 (47.4) | 97 (100.0) | <.01 |
| Self-expanding valve | N/A | 30 (31.3) | |
| Balloon-expanding valve | N/A | 66 (68.7) | |
| Transfemoral TAVR | N/A | 84 (86.6) | |
| In-hospital postoperative outcomes | |||
| Operative mortality (STS definition), n (%) | 1 (1.0) | 0 (0.0) | 1.00 |
| Blood product transfusion, n (%) | 23 (23.7) | 7 (7.2) | <.01 |
| Operative reexploration for bleeding, n (%) | 6 (6.2) | 5 (5.2) | .76 |
| New-onset renal failure requiring dialysis (by RIFLE criteria), n (%) | 3 (3.1) | 2 (2.1) | 1.00 |
| Cerebrovascular accident, n (%) | 3 (3.1) | 0 (0.0) | .25 |
| Major vascular complication, n (%) | 0 (0.0) | 2 (2.1) | .50 |
| New permanent pacemaker requirement, n (%) | 1 (1.0) | 3 (3.1) | .62 |
| Hospital length of stay, d, median (IQR) | 7.0 (5.0-12.0) | 2.0 (1.0-5.0) | <.01 |
| 30-d readmission, n (%) | 14 (14.4) | 14 (14.4) | 1.00 |
| One-month postoperative echocardiography results | N = 52 | N = 65 | |
| Aortic valve mean gradient, mm Hg, median (IQR) | 4.3 (4.3-4.3) | 7.5 (5.0-12.5) | .44 |
| Aortic regurgitation, n (%) | .53 | ||
| None/trace | 49 (94.2) | 56 (86.2) | |
| Mild | 3 (5.8) | 6 (9.2) | |
| Mild-moderate | 0 (0.0) | 2 (3.1) | |
| Moderate | 0 (0.0) | 1 (1.5) | |
| Paravalvular leak (≥moderate), n (%) | 0 (0.0) | 2 (3.1) | |
SAVR, Surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement; N/A, not applicable; STS, Society of Thoracic Surgeons; IQR, interquartile range.
At 1 month, patients who underwent SAVR had similar aortic valve mean gradients as those who underwent TAVR (4.3 mm Hg vs 7.5 mm Hg; P = .44). Moreover, the incidences of aortic regurgitation and moderate or greater paravalvular leak were similar in the 2 groups (P > .05).
Survival and Heart Failure–Related Readmissions
The median duration of follow-up after PSM was 1.8 years (IQR, 1.0-3.4 years) in the TAVR group and 4.5 years (IQR, 1.3-7.2 years) in the SAVR group. Overall, Kaplan-Meier survival estimates were significantly higher in the SAVR group (P < .01, log-rank test), with 1-year survival estimates of 93.6% (95% confidence interval [CI], 87.7%-97.6%) for the SAVR group versus 83.0% (95% CI, 74.8%-89.9%) for the TAVR group (Figure 1). Five-year survival estimates were also higher in matched SAVR versus TAVR patients (79.7% [95% CI, 69.5%-88.2%] vs 46.3% [95% CI, 34.2%-58.6%]) (Figure 1).
Figure 1.
Kaplan-Meier survival estimates for propensity score–matched patients age <65 years who underwent surgical aortic valve replacement (SAVR; n = 97) or transcatheter aortic valve replacement (TAVR; n = 97). Shaded areas indicate 95% confidence intervals.
Moreover, the cumulative incidence of heart failure readmissions in the matched TAVR group was more than double that in the matched SAVR group, with this trend reaching statistical significance on Fine-Gray modeling (P < .01, Gray k-sample test) (Figure 2). To further assess postoperative survival and heart failure readmission results in the context of the shorter observed follow-up in matched TAVR patients, results of restricted mean survival time (RMST) analysis for matched cohorts are provided in Table E3. Finally, rates of aortic valve reintervention after index AVR were similar in the matched SAVR and TAVR groups during the observed follow-up period, with only 1 (1.0%) patient from each group requiring redo valve replacement.
Figure 2.
Competing-risk cumulative incidence estimates of heart failure readmissions after surgical aortic valve replacement (SAVR; n = 97) and transcatheter aortic valve replacement (TAVR; n = 97) in propensity score–matched patients. Shaded areas indicate 95% confidence intervals.
Discussion
In this single-center, propensity score–matched study of postoperative outcomes after SAVR versus TAVR in patients age <65, no significant between-group differences were found in the frequency of immediate postoperative outcomes, including operative mortality and stroke/transient ischemic attack. In addition, echocardiographic follow-up highlighted comparable aortic valve mean gradients and moderate-to-severe paravalvular leak rates in the SAVR and TAVR groups. Finally, compared to the matched SAVR group, the TAVR group had significantly lower Kaplan-Meier survival estimates in the mid-term along with more than double the heart failure readmission rate.
Although these findings should be reaffirmed by larger, propensity score–matched observational studies or randomized controlled trials with longer clinical and echocardiographic follow-up, the data presented here suggest that in patients age <65, TAVR is significantly associated with increased mortality and higher rates of heart failure morbidities compared to SAVR.
Evidence regarding the application of TAVR and its safety profile compared to SAVR is robust. Initial randomized control trials comparing surgical and transcatheter approaches in high-risk patients with severe AS showed that TAVR was noninferior to SAVR in all-cause mortality at 1-, 2-, and 5-year postoperative time points but was associated with higher rates of short-term morbidities, such as major vascular complications and neurologic events.5,15,16 Notably, high-risk patients were mainly octogenarians, with advanced mean age of 83.6 years for TAVR and 84.5 years for SAVR. The comparison of TAVR and SAVR was subsequently expanded to younger intermediate- and low-risk patients (STS risk scores <8%), with studies demonstrating similar trends of noninferior survival but increased periprocedural vascular complications and paravalvular regurgitation in TAVR patients.3,7,17, 18, 19, 20 To reflect the findings of these clinical trials, current AHA/ACC guidelines on the treatment of severe AS were modified to assign TAVR a class I designation for both inoperable and high-risk patients.
Taking into account all the aforementioned clinical trial findings, the average age of studied SAVR and versus TAVR patients across all risk groups ranges from 73 to 85 years.21 For younger patients (age <65 years) with AS, no randomized trials or prospective study data comparing transcatheter and surgical valve replacement techniques have been published to date. A recent study by Alabbadi and colleagues22 analyzing patients age <65 years undergoing AVR was the first to associate TAVR with a significantly higher 6-year mortality rate (23.3% vs 10.5%) and a higher rate of permanent pacemaker implantation (10.7% vs 6.2%) compared to SAVR. Nevertheless, real-world practice has taken the mid-term noninferiority of TAVR compared to SAVR and extrapolated it to this unvalidated age group, with a recent nationwide analysis by Sharma and colleagues12 showing a nearly 3-fold increase in TAVR utilization between 2015 and 2021 (from 17.6% to 47.5%) in patients with AS age <65 years. This trend is in discordance with the 2020 AHA/ACC guidelines on management of severe AS, which support the use of SAVR for adults age <65 years unless life expectancy is limited by comorbidities.10
The use of TAVR in a younger patient demographic brings additional considerations that must be taken into account in the preoperative setting. For example, patients with bicuspid aortic valves often present at earlier ages and classically have been managed with mechanical valves via SAVR.23 Though SAVR versus TAVR randomized control trials excluded patients with bicuspid valves from analysis, in 2020 Halim and colleagues24 reported that 3.2% of TAVR procedures performed in the United States across all age groups were done in patients with bicuspid valve AS. Nationwide data show that early hospital readmissions and mortality in bicuspid valve AS patients age >65 are comparable across AVR modalities25; however, no long-term SAVR versus TAVR comparisons have been reported in younger cohorts. Although the effects on long-term mortality remain unclear, TAVR still may confer an increased risk of postprocedural complications, such as paravalvular leak, in the bicuspid valve AS population compared to traditional SAVR, especially in older-generation transcatheter heart valves (THVs) that lack outer sealing skirts.26 Analyses of bicuspid valve morphology and outcomes after TAVR have revealed potential procedural complexities associated with this unique group, with the presence of calcified raphe and excessive leaflet calcification identified as independent predictors of increased 2-year all-cause mortality.27
Separately, given that TAVR has been used mainly in elderly, octogenarian patients, the durability of bioprosthetic THVs relative to mechanical valves is also unknown. While bioprostheses are anticipated to provide lifelong durability for elderly TAVR patients, individuals age <65 will need ongoing cardiac care throughout their lifetime and may encounter adverse effects due to degeneration of bioprosthetic valves.28 Such factors as future coronary access and the potential need for high-risk surgical explantation of TAVR valves pose significant problems for reintervention, and thus more rigorous evaluation is required before TAVR can be widely adopted in patients age <65 years.29, 30, 31, 32 Although the operative volume is still relatively low, TAVR explantation is known to be a relatively morbid procedure and has become one of the most rapidly growing cardiac surgeries performed over the past 5 to 10 years.33 With THVs being implanted in increasingly younger patients, the number of complex surgical explants may continue to rise concurrently with time.
Here we report that in matched patients age <65 years, TAVR is associated with a significantly higher risk of mortality and higher incidence of heart failure readmission at 5-year follow-up compared to SAVR. It is important to note that even after robust PSM, a majority of young SAVR patients included in this study were prototypically low-risk patients (STS risk score <4%; 81.4%), while the included TAVR patients had a more diverse risk profile, with only 52.6% of the cohort considered low-risk by STS score. Although the results of this retrospective analysis offer valuable insights, they are insufficient to warrant direct changes in current AVR practices in young AS patients. Robust evidence from further comparative studies, particularly randomized controlled trials, is required to justify the prevalent usage of TAVR in patients under age 65.
Limitations
This study has several important limitations. First, the sample sizes of matched TAVR and SAVR groups are relatively small, making the study underpowered to detect differences in outcomes at 5 years. Subsequently, the study's proportion of young bicuspid TAVR patients is likely higher than national averages. All the patients with bicuspid valves who underwent TAVR were deemed at too high risk for SAVR, given poor prognostic factors such as a history of prior coronary artery bypass grafting/percutaneous coronary intervention, chronic renal failure, and poor functional status. Such variables could not be included in our PSM model, as the resulting matched pair counts were too small for analysis. This represents an important limitation of our PSM technique. Even with less strict PSM criteria, we analyzed only 97 pairs of young SAVR patients versus TAVR patients, as only 106 total patients age <65 years underwent TAVR between 2013 and 2023. With such small sample sizes at our single institution, the relative rates of young bicuspid valve patients undergoing TAVR are likely to differ from national rates.
The retrospective, observational design of the study also introduced considerable selection bias in our study, as evidenced by the statistically significant difference in STS risk scores between the SAVR (1.8%) and TAVR (3.9%) groups even after PSM. All young patients who underwent TAVR between 2013 and 2023, regardless of personal preference or preoperative risk, were included in the study. Therefore, despite observed differences in survival outcomes, the results of this study may primarily reflect the heart team's clinical acumen in appropriately selecting TAVR for patients with more severe illness and limited life expectancy.
This analysis incorporated longitudinal data with varying follow-up times, and some patients were lost to follow-up. Moreover, patients included in the TAVR group had disparately shorter follow-up times compared to SAVR patients, thereby biasing Kaplan-Meier survival and cumulative incidence function estimates. Finally, the data are from a single center, which may limit the generalizability of the findings.
Conclusions
Although TAVR patients had shorter clinical follow-up, TAVR was significantly associated with decreased mid-term survival and increased heart failure readmissions compared to SAVR in patients age <65 after propensity score matching. Frequency of post-procedural paravalvular leak was comparable amongst SAVR and TAVR groups following AVR. Further randomized and PSM studies are needed before recommending and implementing TAVR in the under-65 AS patient population.
Conflict of Interest Statement
Dr Sultan reported institutional research support from Abbott, Atricure, Artivion, Edwards Lifesciences, Medtronic, and Terumo Aortic. All other authors reported no conflicts of interest.
The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest.
Footnotes
Drs Ashwat and Yousef contributed equally to this manuscript as co-first authors.
Dr Ibrahim Sultan is an Associate Editor. The peer review process for this paper was handled by Dr Dawn Hui.
Appendix E1
Table E1.
Baseline characteristics in the unmatched cohorts
| Variable | SAVR (N = 655) | TAVR (N = 106) | P value |
|---|---|---|---|
| Age, y, mean ± SD | 55.0 ± 8.9 | 60.1 ± 4.3 | <.01 |
| Female sex, n (%) | 218 (33.3) | 54 (50.9) | <.01 |
| BMI, kg/m2, mean ± SD | 31.2 ± 7.6 | 33.4 ± 11.6 | .01 |
| Diabetes, n (%) | 198 (30.2) | 53 (50.0) | <.01 |
| Hypertension, n (%) | 466 (71.2) | 83 (78.3) | .13 |
| Cardiovascular disease, n (%) | 81 (12.4) | 21 (19.8) | .04 |
| Peripheral vascular disease, n (%) | 29 (4.4) | 26 (24.5) | <.01 |
| Prior cerebrovascular accident, n (%) | 45 (6.9) | 16 (15.1) | <.01 |
| Congestive heart failure, n (%) | 182 (27.8) | 91 (85.9) | <.01 |
| Atrial fibrillation, n (%) | 58 (8.9) | 28 (26.4) | <.01 |
| Long-term dialysis, n (%) | 17 (2.6) | 14 (13.2) | <.01 |
| Chronic lung disease, n (%) | 145 (22.1) | 54 (50.9) | <.01 |
| NYHA class, n (%) | |||
| I | 452 (69.0) | 1 (0.9) | <.01 |
| II | 71 (10.8) | 22 (20.8) | |
| III | 92 (14.1) | 52 (49.1) | |
| IV | 40 (6.1) | 31 (29.3) | |
| Prior PCI/CABG, n (%) | 43 (6.6) | 34 (32.1) | <.01 |
| Aortic valve regurgitation (moderate-severe), n (%) | 283 (43.2) | 25 (23.6) | <.01 |
| Mean aortic gradient, mm Hg, mean SD | 48.4 ± 14.8 | 48.1 ± 14.8 | .87 |
| STS score, %, median (IQR) | 1.0 (0.7-1.6) | 4.0 (2.2-6.3) | <.01 |
| STS score ≤4%, n (%) | 616 (94.1) | 53 (50.0) | |
| STS score 4%-8%, n (%) | 28 (4.3) | 32 (30.2) | |
| STS score >8%, n (%) | 11 (1.7) | 21 (19.8) | |
| Ejection fraction, %, mean ± SD | 56.4 ± 10.8 | 51.2 ± 14.5 | <.01 |
| Bicuspid valve, n (%) | 295 (45.0) | 26 (24.5) | <.01 |
SAVR, Surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement; BMI, body mass index; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; CABG, coronary artery bypass grafting; STS, Society of Thoracic Surgeons; IQR, interquartile range.
Table E2.
Postoperative clinical outcomes in the unmatched cohorts
| Variable | SAVR (N = 655) | TAVR (N = 106) | P value |
|---|---|---|---|
| Aortic implant size, mm, mean ± SD | 24.2 ± 2.5 | 26.7 ± 2.7 | <.01 |
| Valve type, n (%) | |||
| Biologic valve implant | 306 (46.7) | 106 (100.0) | <.01 |
| Self-expanding valve | N/A | 33 (31.4) | |
| Balloon-expanding valve | N/A | 72 (68.6) | |
| Transfemoral TAVR | N/A | 93 (87.7) | |
| Operative mortality (STS definition), n (%) | 0 (0.0) | 5 (0.8) | 1.00 |
| Blood product transfusion, n (%) | 7 (6.6) | 104 (15.9) | .01 |
| New-onset renal failure (by RIFLE criteria) requiring dialysis, n (%) | 2 (1.9) | 7 (1.1) | .36 |
| Cerebrovascular accident, n (%) | 0 (0.0) | 8 (1.2) | .61 |
| New permanent pacemaker requirement, n (%) | 20 (2.6) | 16 (2.4) | .51 |
| Hospital length of stay, d, median (IQR) | 2.0 (1.0-5.0) | 6.0 (4.0-9.0) | <.01 |
| 30-d readmission, n (%) | 16 (15.1) | 70 (10.7) | .18 |
| One-mo postoperative echocardiography results | N = 317 | N = 72 | |
| Aortic valve mean gradient, mm Hg, median (IQR) | 12.6 (4.3-13.8) | 9.0 (7.0-15.2) | .87 |
| Aortic regurgitation, n (%) | .13 | ||
| None/trace | 298 (94.0) | 63 (87.5) | |
| Mild | 14 (4.4) | 6 (8.3) | |
| Mild-moderate | 4 (1.2) | 2 (2.8) | |
| Moderate | 1 (0.3) | 1 (1.4) | |
| Paravalvular leak (≥moderate), n (%) | 1 (0.3) | 2 (2.8) | .09 |
SAVR, Surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement; N/A, not applicable; STS, Society of Thoracic Surgeons; IQR, interquartile range.
Table E3.
Restricted mean survival times in matched patients
| Truncation time | TAVR, y, mean (95% CI) | SAVR, y, mean (95% CI) | P value |
|---|---|---|---|
| Restricted mean survival time | |||
| 3 y | 2.25 (2.03-2.49) | 2.82 (2.68-2.96) | <.001 |
| 5 y | 3.20 (2.79-3.61) | 4.53 (4.28-4.78) | <.001 |
| Restricted mean heart failure-free survival time | |||
| 3 y | 2.10 (1.85-2.25) | 2.64 (2.46-2.82) | <.001 |
| 5 y | 3.16 (2.73-3.59) | 4.61 (4.51-4.71) | <.001 |
TAVR, Transcatheter aortic valve replacement; SAVR, surgical aortic valve replacement; CI, confidence interval.
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