Key Points
Question
What outcomes do patients with low-flow, low-gradient aortic stenosis (LFLG AS) and severely depressed left ventricular function (<30%) experience after transcatheter aortic valve replacement (TAVR)?
Findings
This multicenter registry study of 293 patients with LFLG AS found that, after TAVR, patients with very severe left ventricular dysfunction had greater improvements in left ventricular ejection fraction and similar clinical outcomes as patients with mild left ventricular dysfunction. These clinical outcomes were irrespective of the results of dobutamine stress echocardiography examination.
Meaning
Per these results, patients with LFLG AS should not be declined for TAVR on the basis of left ventricular dysfunction severity or dobutamine stress echocardiography results; TAVR appears to be a good alternative treatment for patients with LFLG AS and severe left ventricular dysfunction.
This multicenter registry study evaluates the clinical outcomes and changes in left ventricular ejection fraction after transcatheter aortic valve replacement in patients with low-flow, low-gradient aortic stenosis and severe left ventricular dysfunction.
Abstract
Importance
In low-flow, low-gradient aortic stenosis (LFLG AS), the severity of left ventricular dysfunction remains a key factor in the evaluation of aortic valve replacement.
Objective
To evaluate the clinical outcomes and changes in left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR) in patients with LFLG AS and severe left ventricular dysfunction.
Design, Setting, and Participants
This multicenter registry is a substudy of the True or Pseudo-Severe Aortic Stenosis–TAVI registry that included patients with classic LFLG AS, defined as a mean transvalvular gradient less than 35 mm Hg, an effective orifice area less than 1.0 cm2, and an LVEF of 40% or less. Patients were divided in groups with very low (<30%) LVEF and low (30%-40%) LVEF. Dobutamine stress echocardiography (DSE) was performed before TAVR in a subset with very low LVEF, and presence of contractile reserve was defined as an increase of 20% or more in stroke volume. Clinical outcomes were assessed at 1 and 12 months and yearly thereafter, and echocardiography was performed at 1-year follow-up. Retrospective data were collected from 2007 to 2013 and prospective data from January 2013 to March 2018. Data were analyzed from March to October 2018.
Exposures
Transcatheter aortic valve replacement in patients with LFLG AS.
Main Outcomes and Measures
Changes in LVEF over time; periprocedural and late mortality.
Results
A total of 293 patients were included, including 128 (43.7%) with very low LVEF and 165 with low LVEF (56.3%). Their mean (SD) age was 80 (7) years, and most (214 [73.0%]) were men. The mean (SD) LVEF in the very low LVEF group was 22% (5%), compared with 37% (7%) in the low LVEF group (P < .001). There were no differences between groups in rates of periprocedural mortality and late mortality (median [interquartile range], 23 [6-38] months). Patients with very low LVEF displayed a greater increase in LVEF at the 1-year follow-up examination (mean absolute increase, 11.9% [95% CI, 8.8%-15.1%]), than the low LVEF group (3.6% [95% CI, 1.1%-6.1%]; P < .001). In 92 patients with very low LVEF who had preprocedural DSE, results showed a lack of contractile reserve in 45 (49%), but this had no effect on clinical outcomes or changes in LVEF over time.
Conclusions and Relevance
In patients with LFLG AS and severe left ventricular dysfunction, TAVR was associated with similar clinical outcomes as in counterparts with milder left ventricular dysfunction. The TAVR procedure was associated with a significant increase in LVEF, irrespective of contractile reserve. These results support TAVR for LFLG AS, irrespective of the severity of left ventricular dysfunction and DSE results.
Introduction
Patients with aortic stenosis (AS) and left ventricular (LV) dysfunction, particularly those with a low-flow, low-gradient (LFLG) pattern, have greater perioperative risk and poorer outcomes.1,2,3,4 Some analyses of retrospective data and the recent first report from the True or Pseudo-Severe Aortic Stenosis–Transcatheter Aortic Valve Implantation (TOPAS-TAVI) registry have shown acceptable early and late outcomes after transcatheter aortic valve replacement (TAVR) in patients with low-flow, low-gradient aortic stenosis (LFLG AS).5,6,7 However, data on patients with severely depressed left ventricular ejection fraction (LVEF) (<30%) are scarce, and to our knowledge, no study to date has specifically focused on this challenging group of patients. The objective of this study was to determine the clinical outcomes and changes in LVEF over time in those patients with LFLG AS and LVEF less than 30%.
Methods
This was a multicenter registry including consecutive patients with LFLG AS undergoing TAVR procedures. Classic LFLG AS was defined by a mean transvalvular gradient less than 35 mm Hg, an effective orifice area less than 1.0 cm2, and an LVEF of 40% or less. The patients were part of a substudy of the TOPAS multicenter registry (NCT01835028). Patient enrollment and data collection started in January 2013, and patients were prospectively enrolled in 14 centers until March 2018. In addition, data from patients treated from 2007 to 2013 in 9 centers were collected retrospectively. Patients were separated into 2 groups according to baseline LVEF (as determined by echocardiography): less than 30% (n = 128 [43.7%]); very low LVEF group), and 30% or more (n = 165 [56.3%]; low LVEF group).
Patients were followed up by clinical visits or telephone contact at 1 and 12 months and yearly thereafter. The ethics committee at each participating center approved the study, and written informed consent was obtained from all participants included prospectively; for those included retrospectively, consent was waived, according to institutional review board approval for the study.
Doppler Echocardiography
Patients underwent a transthoracic echocardiography exam pre-TAVR, at hospital discharge, and at 1 year post-TAVR. A dobutamine stress echocardiography (DSE) examination was performed at baseline in 92 of the 128 patients (71.2%) in the very low LVEF group, according to standard protocols.8,9 The presence of contractile reserve (or flow reserve) was defined as a percent increase in stroke volume of 20% or more during the DSE examination.
End Points
The end points were (1) changes in LVEF over time, per LVEF subgroups (very low LVEF vs low LVEF) and DSE examination results (presence vs absence of contractile reserve) and (2) mortality in the periprocedural (30-day) period and the remainder of the follow-up period, per LVEF subgroups. Clinical events were recorded and defined according to the Valve Academic Research Consortium–2 consensus.10
Statistical Analysis
Continuous data were expressed as mean (SD) or median (interquartile range) and were tested for the normality of distribution with the Shapiro-Wilk test. Categorical data were expressed as number and percentage. Clinical and echocardiographic characteristics between groups were compared with the t test or the Wilcoxon rank sum test for continuous variables and with the χ2 test or Fisher exact test for categorical variables. Kaplan-Meier curves and log-rank tests of the time-to-event data were used to evaluate overall and cardiac mortality, as well as stroke. An analysis of variance for repeated-measures model with interaction was used to analyze the changes in LVEF over time. Posterior comparisons were performed using the Tukey technique. All analyses were performed using a hierarchical method to account for between-center variability. A P value <.05 was considered statistically significant. Analyses were conducted using the statistical packages in SAS version 9.4 (SAS Institute Inc). Statistical analyses were performed from March 2018 to October 2018.
Results
Two hundred patients were enrolled at study centers and the retrospective data of an additional 93 individuals were added, leading to a total study population of 293 patients. Mean (SD) age was 80 (7) years, and 214 participants (73.0%) were men. Clinical, echocardiographic, and procedural characteristics of the study population, overall and according to LVEF, are shown in Table 1. Patients in the very low LVEF group, compared with the low LVEF group, exhibited a higher rate of prior myocardial infarction (56 [43.8%] vs 52 [31.5%]; P = .03) and had more frequently concomitant moderate to severe aortic regurgitation (41 [32.0%] vs 32 [19.4%]; P = .01) and moderate to severe mitral regurgitation (55 [43.0%] vs 48 [29.1%]; P = .01).
Table 1. Clinical and Procedural Characteristics of the Study Population, Overall and According to the Severity of Left Ventricular Dysfunction.
| Variable | No. (%) | P Value | ||
|---|---|---|---|---|
| All Patients (N = 293) | Patients With Very Low LVEF (n = 128) | Patients With Low LVEF (n = 165) | ||
| Clinical Variables | ||||
| Age, mean (SD), y | 80 (7) | 80 (8) | 81 (7) | .09 |
| Male | 214 (73.0) | 89 (69.5) | 125 (75.8) | .24 |
| BMI, median (IQR) | 26 (23-30) | 26 (23-30) | 26 (23-29) | .73 |
| New York Heart Association class III or IV | 245 (83.6) | 108 (84.4) | 137 (83.0) | .63 |
| Hypertension | 245 (83.6) | 108 (84.4) | 137 (83.0) | .87 |
| Diabetes mellitus | 123 (42.0) | 58 (45.3) | 65 (39.4) | .34 |
| Coronary artery disease | 222 (75.8) | 96 (75.0) | 126 (76.4) | .79 |
| Medical history | ||||
| Myocardial infarction | 108 (36.9) | 56 (43.8) | 52 (31.5) | .03 |
| Percutaneous coronary intervention | 135 (46.1) | 58 (45.3) | 77 (46.7) | .81 |
| Coronary artery bypass graft | 119 (40.6) | 48 (37.5) | 71 (43.0) | .40 |
| Atrial fibrillation | 141 (48.1) | 61 (47.7) | 80 (48.5) | .81 |
| Peripheral vascular disease | 88 (30.0) | 41 (32.0) | 46 (27.9) | .44 |
| Chronic obstructive pulmonary disease | 104 (35.5) | 46 (35.9) | 58 (35.2) | .90 |
| Left branch bundle block | 64 (21.8) | 30 (23.4) | 34 (20.6) | .57 |
| Porcelain aorta | 26 (8.9) | 11 (8.6) | 15 (9.1) | >.99 |
| Hemoglobin level, mean (SD), g/dL | 11.9 (1.7) | 12.0 (1.7) | 11.8 (1.7) | .36 |
| Estimated glomerular filtration rate, median (IQR), mL/min/1.73 m2 | 58 (44-76) | 58 (43-78) | 59 (45-76) | .70 |
| Chronic kidney diseasea | 161 (54.9) | 68 (53.1) | 93 (56.4) | .64 |
| STS-PROM, median (IQR), % | 7.7 (5.3-12.0) | 8.9 (5.6-12.9) | 7.2 (5.0-11.3) | .22 |
| Echocardiographic variables | ||||
| LVEF, mean (SD), % | 31 (9) | 22 (5) | 37 (7) | <.001 |
| Peak jet velocity, mean (SD), m/s | 3.27 (0.41) | 3.25 (0.41) | 3.29 (0.40) | .50 |
| Mean aortic gradient, mean (SD), mm Hg | 25 (7) | 24 (7) | 26 (6) | .03 |
| Aortic valve area, mean (SD), cm2 | 0.76 (0.20) | 0.76 (0.22) | 0.76 (0.19) | .93 |
| Moderate to severe aortic regurgitation | 73 (24.9) | 41 (32.0) | 32 (19.4) | .01 |
| Moderate to severe mitral regurgitation | 103 (35.2) | 55 (43.0) | 48 (29.1) | .01 |
| Stroke volume, mean (SD), mL | 55 (1) | 52 (16) | 56 (15) | .05 |
| Stroke volume index, mean (SD), mL/min/m2 | 30 (8) | 29 (9) | 31 (8) | .05 |
| Pulmonary systolic artery pressure, mean (SD), mm Hg | 47 (15) | 49 (15) | 45 (14) | .06 |
| Procedural Variables | ||||
| Procedural successb | 258 (88.1) | 110 (85.9) | 148 (89.7) | .37 |
| Prosthesis type | ||||
| Sapien | 126 (43.0) | 51 (39.8) | 75 (45.5) | .39 |
| Sapien XT | 86 (29.4) | 45 (35.2) | 41 (24.8) | |
| Sapien 3 | 25 (8.5) | 8 (6.3) | 17 (10.3) | |
| CoreValve | 49 (16.7) | 22 (17.2) | 27 (16.4) | |
| Evolut R | 3 (1.0) | 1 (0.78) | 2 (1.2) | |
| Othersc | 4 (1.4) | 1 (0.78) | 3 (1.8) | |
| Prosthesis size, mm | ||||
| 20 | 2 (0.7) | 1 (0.8) | 1 (0.6) | .99 |
| 23 | 50 (17.1) | 23 (18.0) | 27 (16.4) | |
| 26 | 127 (43.3) | 54 (42.2) | 73 (44.2) | |
| 27 | 2 (0.7) | 1 (0.78) | 1 (0.6) | |
| 29 | 89 (30.4) | 41 (32.0) | 48 (29.1) | |
| 31 | 17 (5.8) | 7 (5.5) | 10 (6.1) | |
| Approach | ||||
| Transfemoral | 204 (69.6) | 96 (75.0) | 108 (65.5) | .33 |
| Transapical | 59 (20.1) | 21 (16.4) | 38 (23.0) | |
| Transaortic | 16 (5.5) | 6 (4.7) | 10 (6.1) | |
| Transsubclavian | 11 (3.8) | 3 (2.3) | 8 (4.8) | |
| Transcaval | 3 (1.0) | 2 (1.6) | 1 (0.6) | |
| Postdilatation | 51 (17.4) | 25 (19.5) | 26 (15.8) | .44 |
| Postprocedure echocardiography | ||||
| Aortic gradient, mean (SD), mm Hg | 9 (4) | 8 (3) | 9 (4) | .15 |
| Aortic valve area, mean (SD), cm2 | 1.7 (0.6) | 1.7 (0.5) | 1.7 (0.6) | .68 |
| Residual moderate/severe aortic regurgitation | 23 (8.1) | 12 (9.8) | 11 (6.9) | .51 |
| LVEF, mean (SD), % | 36 (12) | 28 (9) | 42 (11) | <.001 |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); IQR, interquartile range; LVEF, left ventricular ejection fraction; STS-PROM, Society of Thoracic Surgeons–Predicted Risk of Mortality.
SI conversion factors: To convert estimated glomerular filtration rate to milliliters per second, multiply by 0.0167; to convert hemoglobin to grams per liter, multiply by 10.0.
Defined as an estimated glomerular filtration rate of less than 60 mL/min.
Per Valve Academic Research Consortium–2 criteria.
Includes Portico, Lotus, and Directflow.
Clinical Outcomes
The 30-day mortality rate was 4.1% (12 of 293 participants), with no differences between groups (very low LVEF, 6 of 128 participants [4.7%]; low LVEF, 6 of 165 participants [3.6%]; P = .65). There were no differences between groups in the rate of periprocedural complications (Table 1). At a median follow-up of 23 (interquartile range [IQR], 6-38) months, a total of 132 patients (45.1%) died, with no differences between the very low LVEF group (57 [44.5%]) and the low LVEF group (75 [45.5%]; hazard ratio [HR], 0.96 [95% CI, 0.61-1.53]; P = .88). Early and late clinical outcomes of the study population, overall and according to LVEF, are shown in eTable 1 and the eFigure in the Supplement.
Echocardiography Data
At the 1-year follow-up examination, an echocardiographic examination was available in 156 of 235 patients at risk (66.4%; 72 of 98 patients [74%] in the very low LVEF group and 84 of 137 patients [61%] in the low LVEF group). The changes in LVEF over time are shown in the Figure, A. Overall, there was a significant increase in LVEF at 1-year follow-up (22% [95% CI, 18%-26%]; P < .001), and the increase was greater in the very low LVEF group (33% [95% CI, 25%-41%]; P < .001) compared with the low LVEF group (14% [95% CI, 10%-18%]; P < .001).
Figure. Changes in Left Ventricular Ejection Fraction (LVEF) Over Time.
A, Changes in LVEF over time according to the severity of left ventricular dysfunction (<30% vs ≥30%); The LVEF increased mean (SD) from 37% (7%) at baseline to 41% (12%) at 1-year follow-up in the group with LVEF of 30% or greater and from 22% (5%) to 34% (12%) in the group with LVEF less than 30% (P < .001). B, Changes in LVEF over time in patients with severe left ventricular dysfunction (LVEF<30%), according to the presence, absence, or unknown status of contractile reserve at dobutamine stress echocardiography before transcatheter aortic valve replacement; P < .001 for changes over time between groups. In patients with contractile reserve, the LVEF increased from a mean (SD) of 23% (5%) at baseline to 35% (12%) at 1-year follow-up (P < .001). In patients without contractile reserve, the LVEF increased from 21% (5%) at baseline to 33% (13%) at 1-year follow-up (P < .001). In patients with unknown contractile reserve, the LVEF increased from 22% (5%) at baseline to 35% (13%) at 1-year follow-up (P < .001).
Data from the pre-TAVR DSE examinations performed in the very low LVEF group are summarized in Table 2. At a mean (SD) dobutamine peak dose of 20 (6) μg/kg/min, mean (SD) aortic valve area was 0.83 (0.33) cm2, mean (SD) transvalvular gradient was 36 (10) mm Hg, and mean (SD) LVEF was 29% (8%). The mean (SD) values for stroke volume and stroke volume index at peak stress were 64 (21) mL and 35 (11) mL/m2, respectively. The mean percent increase in stroke volume was 22% (IQR, 2%-45%). A total of 47 patients (51.1%) had 20% or greater increase in stroke volume, consistent with the presence of contractile reserve. There were no differences in baseline clinical characteristics between patients with and without contractile reserve (eTable 2 in the Supplement). The DSE data failed to predict LVEF recovery post-TAVR, because patients with contractile reserve experienced the same change in LVEF as those without contractile reserve (mean [SD] relative increase of 27% [35%] vs 26% [42%]; P = .95; Figure, B). There were no differences between patients with very low LVEF with and without contractile reserve regarding early and late clinical events (eTable 3 in the Supplement).
Table 2. Dobutamine Stress Echocardiography Data in Patients With Left Ventricular Ejection Fraction Less Than 30%, Overall and According to the Presence of Contractile Reserve.
| Variable | Values, Mean (SD) | |||
|---|---|---|---|---|
| All Patients With LVEF <30% and Dobutamine Stress Echocardiography Data (n = 92) | Patients With No Contractile Reserve (n = 45) | Patients With Contractile Reserve (n = 47) | P Value | |
| Dobutamine peak dose, μg/kg/min | 19.6 (6.1) | 19.1 (5.2) | 20.1 (6.9) | .45 |
| LVEF, % | ||||
| Baseline | 22 (5) | 21 (5) | 23 (5) | .10 |
| Peak | 29 (8) | 27 (8) | 31 (8) | .05 |
| Peak jet velocity, m/s | ||||
| Baseline | 3.23 (0.41) | 3.29 (0.33) | 3.19 (0.46) | .26 |
| Peak | 3.92 (0.54) | 3.85 (0.59) | 3.98 (0.49) | .33 |
| Aortic gradient, mm Hg | ||||
| Baseline | 24 (7) | 25 (6) | 24 (8) | .36 |
| Peak | 36 (10) | 35 (11) | 38 (10) | .22 |
| Aortic valve area, cm2 | ||||
| Baseline | 0.77 (0.19) | 0.76 (0.23) | 0.76 (0.20) | .98 |
| Peak | 0.83 (0.33) | 0.78 (0.39) | 0.87 (0.26) | .19 |
| Stroke volume, mL | ||||
| Baseline | 52 (15) | 54 (17) | 49 (16) | .12 |
| Peak | 64 (21) | 54 (1) | 72 (22) | NA |
| Stroke volume index, mL/min/m2 | ||||
| Baseline | 28 (8) | 30 (9) | 27 (8) | .04 |
| Peak | 35 (11) | 30 (8) | 39 (11) | NA |
| Increase in stroke volume, median (interquartile range), % | 22 (2-45) | 1 (−10 to 9) | 45 (30-61) | NA |
Abbreviations: LVEF, left ventricular ejection fraction; NA, not applicable.
Discussion
The main results of this study can be summarized as follows: in patients with low transvalvular gradient and severely depressed LVEF (in this study, with a mean LVEF of approximately 20%), (1) LVEF values significantly improved post-TAVR, with a mean LVEF greater than 30% at 1-year follow-up; (2) the presence or absence of contractile reserve during DSE pre-TAVR was not associated with LVEF changes over time or clinical outcomes; and (3) the periprocedural and long-term post-TAVR outcomes are similar to those in patients with mildly depressed LVEF.
Patients with severe AS and depressed left ventricular function represent a minority (approximately 5%) of the population with AS. The initial report of the TOPAS-TAVI registry showed that patients with classic LFLG AS exhibited acceptable 2-year clinical outcomes, and the severity of LV dysfunction at baseline (with LVEF evaluated as a continuous variable) had no significant association with clinical outcomes or LVEF changes over time.7 In this substudy from the TOPAS-TAVI registry, we provide further details on the group of patients with severely depressed LVEF (with a mean LVEF close to 20%), who exhibited early and late clinical outcomes similar to their counterparts with mildly depressed LVEF values. Nevertheless, more than 40% of patients died after a mean follow-up of 2 years, reflecting the high-risk profile of this population.
Prior studies in the TAVR field have shown that LVEF often improves substantially post-TAVR.11,12,13 Moreover, some authors have suggested that patients with severe left ventricular dysfunction derive greater health status benefits from TAVR than patients with preserved left ventricular function.13,14 In line with these data, our results suggest that patients with LFLG AS and severely depressed LVEF at baseline derive greater benefit in terms of increase in LVEF compared with patients with mildly depressed LVEF. These changes were irrespective of the lack of contractile reserve determined by the DSE examination pre-TAVR. The initial report from the TOPAS-TAVI registry had already demonstrated the lack of association with the results of DSE on left ventricular function recovery and clinical outcomes, and the present study further extends these observations to those patients with very low LVEF.7 Thus, in patients with LFLG AS, TAVR should not be declined on the basis of the severity of left ventricular dysfunction or the lack of contractile reserve at DSE. These results are also in accordance with prior studies in the SAVR and TAVR field, showing the lack of prognostic value of DSE in patients with LFLG AS.8,15
Limitations
Whereas most patients were included in this registry prospectively, data were collected retrospectively in about one-third of the patients. Also, DSE examinations were not performed in 28% of the patients in the very low LVEF group, and no systematic data were obtained on Agatston calcium score and projected valve area. While patient characteristics were similar between groups, we cannot completely rule out some potential patient selection bias, particularly regarding the group of patients with very low LVEF. Finally, the results regarding clinical outcomes should be interpreted with caution because of the relative low number of patients included in both groups.
Conclusions
In patients with LFLG AS and severe left ventricular dysfunction, TAVR was feasible and was associated with similar clinical outcomes in those patients with only mildly depressed LVEF function. Importantly, most patients demonstrated a significant improvement in their LVEF over time, irrespective of the degree of baseline LV dysfunction and the presence or lack of contractile reserve. Thus, patients with LFLG severe AS should not be declined for aortic valve replacement procedures on the basis of the degree of LVEF dysfunction or the results of DSE.
eTable 1. 30-Day and Late Outcomes, Overall and According to the Severity of LV Dysfunction.
eTable 2. Clinical and Procedural Characteristics in Patients with Severely Depressed (<30%) LVEF, According to the Presence of Contractile Reserve at Dobutamine Stress Echocardiography.
eTable 3. Clinical Outcomes of the Patients with VL-LVEF, According to the Presence of Contractile Reserve During Dobutamine-Stress Echocardiography.
eFigure. Clinical events at 5-year follow-up, according to the severity of LV dysfunction (<30% vs. ≥30%).
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
eTable 1. 30-Day and Late Outcomes, Overall and According to the Severity of LV Dysfunction.
eTable 2. Clinical and Procedural Characteristics in Patients with Severely Depressed (<30%) LVEF, According to the Presence of Contractile Reserve at Dobutamine Stress Echocardiography.
eTable 3. Clinical Outcomes of the Patients with VL-LVEF, According to the Presence of Contractile Reserve During Dobutamine-Stress Echocardiography.
eFigure. Clinical events at 5-year follow-up, according to the severity of LV dysfunction (<30% vs. ≥30%).