Abstract
Background
The Small Annuli Randomized to Evolut or SAPIEN Trial showed superior hemodynamics of self-expanding valves (SEVs) over balloon-expandable valves (BEVs) in patients with small aortic annuli (SAA). The long-term clinical implications of these hemodynamic differences are unknown.
Methods
We conducted an observational cohort study of patients with SAA, defined as an aortic valve annular area ≤430 mm 2 on cardiac computed tomography, who underwent transcatheter aortic valve replacement using BEV or SEV at a single institution between August 2013 and February 2021. Patients undergoing valve-in-valve procedures or alternative access were excluded. Patient-prosthesis mismatch (PPM) was defined as moderate when indexed effective orifice area of 0.65-0.85 cm 2 /m 2 and severe when indexed effective orifice area was <0.65 cm 2 /m 2 (or <0.55 cm 2 /m 2 for body mass index >30 kg/m 2 ). The primary outcome of the study was mortality and major adverse cardiovascular events.
Results
A total of 258 patients were included. The majority were female (81%) with intermediate surgical risk (median STS risk score 4.23); 90 patients (35%) received a BEV (median age 80 years [73, 86]) and 168 (65%) received a SEV (81 years [75, 85], p = 0.699). Comorbidities and risk profiles were well balanced between groups. At 30 days post-transcatheter aortic valve replacement, SEV had lower aortic valve mean gradients (8 mmHg [6, 11] vs. BEV 14 mmHg [10, 18], p < 0.001), lower peak velocities (1.86 m/s [1.60, 2.34] vs. BEV 2.52 m/s [2.14, 2.90], p < 0.001), and were less likely to have PPM (SEV 18% vs. BEV 42% ( p < 0.001). At 3 years, both groups had similar mortality (SEV 23% vs. BEV 22%, p = 0.875). PPM was not associated with long-term mortality.
Conclusions
In patients with SAA, we observed no difference in mortality between SEV and BEV up to 3 years after the index procedure, despite early differences in valve hemodynamics.
Highlights
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Among patients with small aortic annuli, self-expanding valves had better hemodynamics than balloon-expandable valves.
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There is no difference in 3-year mortality or major adverse cardiovascular events between self-expanding valves and balloon-expandable valves.
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Our study confirms and extends the results of the Small Annuli Randomized to Evolut or SAPIEN Trial.
Introduction
Patient-prosthesis mismatch (PPM) is associated with worse clinical outcomes after surgical aortic valve (AV) replacement. , Although transcatheter heart valves (THVs) do not have a sewing ring and can generally achieve larger effective orifice areas (EOAs) than surgical valves, there are anatomical subsets that are at risk of PPM, including small aortic annulus, valve-in-valve procedures, and patients with a large body surface area.
PPM affects one in three patients undergoing commercial transcatheter aortic valve replacement (TAVR) in the United States, with most cases being of moderate severity. There is conflicting information regarding the prognosis of PPM after TAVR. , In the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) registry, severe PPM was associated with an increased risk of death and heart failure rehospitalization at 1-year. In a subsequent analysis by Tang et al. focusing on supra-annular THV devices, PPM was significantly less common (5.3%) and not associated with worse clinical outcomes. To better understand the role of THV design (self-expanding and supra-annular vs. balloon expandable and intra-annular) on PPM after TAVR and its clinical implications, we conducted an observational study comparing both platforms in patients with small aortic annulus.
Methods
We conducted an observational cohort study of consecutive patients with small aortic annulus, defined as an AV annular area ≤430 mm 2 on cardiac computed tomography, who underwent TAVR using commercially available THV at a single institution (The Christ Hospital, Cincinnati, OH) between August 2013 and February 2021. Patients undergoing valve-in-valve procedures or alternative access were excluded.
We compared the Edwards SAPIEN 3/Ultra balloon-expandable valve (BEV group) vs. the Medtronic Evolut R/PRO self-expanding valve (SEV group) in patients with small aortic annulus (SAA). PPM was considered moderate when the indexed effective orifice area was between 0.65 and 0.85 cm 2 /m 2 and severe when <0.65 cm 2 /m 2 (or indexed effective orifice area <0.55 cm 2 /m 2 if body mass index is > 30 kg/m 2 ). Demographic and clinical variables were captured from electronic medical records using Transcatheter Valve Therapy data collection forms. Clinical outcomes were defined according to the Valve Academic Research Consortium-3 definitions. The primary outcome of the study was mortality and major adverse cardiovascular events (MACE), defined as a composite of death, stroke, and myocardial infarction at 3 years. Secondary outcomes included the incidence and prognosis of moderate/severe PPM.
Statistical Analysis
Continuous variables are presented as mean ± standard deviation if normally distributed or median (interquartile range) if skewed. Differences in continuous variables were assessed using a student’s t-test or Wilcoxon rank-sum test, depending on the distribution. Discrete variables are presented as counts and percentages, with differences assessed using the chi-square test or Fisher’s exact test, where appropriate. Kaplan-Meier curves were used to present survival free of mortality and survival free of MACE. Differences in survival distributions were tested using the log-rank test. To minimize the risk of bias, propensity score matching using four pretreatment variables (age, gender, STS score, and bicuspid valve) was performed. All analyses were performed in Stata version 17.0 (College Station, TX). The study was approved by the local institutional review board, and informed consent was waived.
Results
A total of 258 patients with SAA, out of 1188 TAVR procedures, underwent TAVR during the study period and were included in the study. The baseline clinical characteristics of the study cohort are presented in Table 1 . There was a high preponderance of female gender (81%) with multiple comorbidities and intermediate surgical risk (median STS risk score 4.23 [2.57, 6.19]). A total of 90 patients (35%) received a BEV (median age 80 years [73, 86]) and 168 (65%) received a SEV (median age 81 years [75, 85], p = 0.699). The groups were well balanced in regard to comorbidities and risk profile ( Table 1 ).
| Variable | Overall (N = 258) | Balloon-expandable valve (N = 90) | Self-expanding valve (N = 168) | p value |
|---|---|---|---|---|
| Sex – female, n (%) | 210 (81) | 65 (72) | 145 (86) | 0.006 |
| Age, median (IQR) | 80.8 (74.8, 86.2) | 80.0 (73.6, 86.5) | 81.0 (75.5, 85.8) | 0.699 |
| Caucasian race, n (%) | 242 (94) | 85 (94) | 157 (93) | 0.753 |
| Atrial fibrillation, n (%) | 111 (43) | 32 (36) | 79 (47) | 0.076 |
| Prior stroke, n (%) | 29 (11) | 13 (14) | 16 (10) | 0.233 |
| Chronic lung disease, n (%) | 106 (41) | 34 (38) | 72 (43) | 0.429 |
| Diabetes, n (%) | 93 (36) | 35 (39) | 58 (35) | 0.486 |
| Prior endocarditis, n (%) | 5 (2) | 1 (1) | 4 (2) | 0.661 |
| Heart failure, n (%) Within 2 weeks of procedure | 233 (90) | 81 (90) | 152 (90) | 0.902 |
| Hostile chest, n (%) | 18 (7) | 3 (3) | 15 (9) | 0.124 |
| Hypertension, n (%) | 222 (86) | 78 (87) | 144 (86) | 0.833 |
| Prior MI, n (%) | 94 (36) | 33 (37) | 61 (36) | 0.955 |
| Peripheral artery disease, n (%) | 90 (35) | 30 (33) | 60 (36) | 0.702 |
| Porcelain aorta, n (%) | 8 (3) | 2 (2) | 6 (4) | 0.717 |
| Prior TIA, n (%) | 32 (12) | 13 (14) | 19 (11) | 0.467 |
| Home oxygen, n (%) | 24 (9) | 5 (6) | 19 (11) | 0.129 |
| Dialysis, n (%) | 11 (4) | 6 (7) | 5 (3) | 0.162 |
| Tobacco use, n (%) | 22 (9) | 8 (9) | 14 (8) | 0.879 |
| Prior CABG, n (%) | 55 (21) | 25 (28) | 30 (18) | 0.064 |
| Prior ICD, n (%) | 17 (7) | 3 (3) | 14 (8) | 0.187 |
| Mitral valve procedure, n (%) | 12 (5) | 2 (2) | 10 (6) | 0.224 |
| Prior PCI, n (%) | 91 (35) | 36 (40) | 55 (33) | 0.245 |
| Prior PPM, n (%) | 34 (13) | 12 (13) | 22 (13) | 0.957 |
| Pre-NYHA class, n (%) | 0.185 | |||
| I | 1 (0) | 0 (0) | 1 (1) | |
| II | 51 (20) | 17 (19) | 34 (20) | |
| III | 152 (59) | 60 (67) | 92 (55) | |
| IV | 53 (21) | 13 (14) | 40 (24) | |
| Cardiogenic shock, n (%) | 12 (5) | 2 (2) | 10 (6) | 0.225 |
| STS risk score, median (IQR) | 4.23 (2.57, 6.19) | 4.46 (2.55, 6.53) | 4.20 (2.61, 5.97) | 0.620 |
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