Abstract
Background
Transcatheter aortic valve implantation (TAVI) is an alternative treatment for surgically high-risk patients with severe aortic stenosis (AS). This study aimed to assess the echocardiographic outcomes of TAVI in patients with severe AS, focusing on left ventricular mass, volume, and pressure.
Methods
This retrospective, registry-based, single-center study was conducted at King Salman Heart Center, Riyadh, Saudi Arabia. We included 200 adult patients who underwent the TAVI procedure and completed at least one year of clinical and echocardiographic follow-up. Baseline demographic, clinical, and echocardiographic data were collected and paired pre- and post-procedure echocardiographic measurements were analyzed.
Result
Paired analysis in comparison of pre and post-transcatheter aortic valve implantation (TAVI) shows significant improvement in left ventricular (LV) mass, volume, and pressure.
Conclusion
This study demonstrates that transcatheter aortic valve implantation (TAVI) leads to significant improvement in key echocardiographic parameters such as left ventricular (LV) size, functions, mass, and ejection fractions (EF).
Keywords: Aortic valve stenosis, Echocardiography, Left ventricular mass, Left ventricular volume, Left ventricular pressure
1. Introduction
Aortic valve stenosis (AS) is a common valvular disease, especially in the elderly population that may need surgical management [1,2]. About 1–2 % in patients aged 65 or less and also 29 % in patients aged 65 or above. About 2–9 % of patients aged greater than 75 have severe aortic stenosis [17,18]. Left ventricular (LV) obstruction is caused by the stenosis of the valve and that increases LV systolic pressure. It also results in decreased aortic pressure, increased LV ejection time (LVET), and increased LV end-diastolic pressure. The increased afterload, more to an increase in LV volume overload, leads to an increase in LV mass [19].
The current gold standard treatment for symptomatic patients is transcatheter aortic valve implantation (TAVI) in patients with moderate and high risk for surgical intervention. Current evidence points TAVI vs. medical therapy in patients with critical AS to the clinical superiority of TAVI in inoperable patients, and TAVI is now deemed equivalent to conventional surgical aortic valve replacement (SAVR) in severe AS patients at high-risk surgicali [20,21]. Aortic valve replacement (AVR) by surgical intervention has been well-validated in multiple studies [3–8]. One-third of the patients, do not agree to surgical options because of old age, multiple co-morbidities, and high surgical risk [1], other evidence suggests TAVI provides a better hemodynamic and clinical improvement for the first two years [3].
Aortic stenosis can cause increased left ventricular (LV) afterload, which can lead to left ventricular (LV) hypertrophy and remodeling leading to symptoms of heart failure, and also can increase morbidity, and mortality [9,10]. The surgical interventions have been proven to decrease LV mass and improve systolic, and diastolic LV functions and parameters, which can also increase survival rate. TAVI, in the other study, can improve diastolic LV function and favor left ventricular mass regression (LVMR) [1,10].
The Objective, the current study aims to examine the impact of transcatheter aortic valve implantation (TAVI) on the left ventricular mass, volume, and pressure using echocardiographic analysis.
2. Materials and methods
This retrospective, registry-based, single-center study was conducted at King Salman Heart Center, Riyadh, Saudi Arabia. We included 200 adult patients who underwent the TAVI procedure and completed at least one year of clinical and echocardiographic follow-up. Baseline demographic, clinical, and echocardiographic data were collected and paired pre- and post-procedure echocardiographic measurements were analyzed.
2.1. Diagnostic criteria
The diagnosis of severe Aortic Stenosis (AS) was established either by transthoracic echocardiogram (TTE) or Transesophageal echocardiogram (TEE).
2.2. Data collection
Data were collected using a standardized case report form that included the following information: demographic and clinical characteristics echocardiographic parameters such as Left ventricular internal diameter end diastole and end systole (LVIDd and LVIDs), Left Ventricle End diastolic Volume (LVEDV), Left ventricular ejection fraction (LVEF), Stroke volume index, Aortic Peak, mean PG, Aortic valve area, Aortic annulus size, RV Basal Diameter (mm), Tricuspid Annular Plane Systolic Excursion (TAPSE), right ventricular systolic pressure (RVSP), right, left atrial volume index (RAVI, LAVI) Left ventricular mass index (LVMi), E/A ratio, types of Aortic stenosis and TAVI, aortic regurgitation (AR), mitral regurgitation (MR), tricuspid regurgitation (TR), risk factors, diagnostic methods, management, and outcome. Demographic and clinical characteristics included the age at diagnosis; sex; body mass index (BMI) category; history of hypertension, dyslipidemia diabetes, smoking, coronary artery disease (CAD), heart failure, stroke or TIA, symptoms, Continuous variables, such as age, BMI, HR, RR, SBP, DBP, were expressed as median [interquartile range].
2.3. Ethical considerations
The study was approved by the institutional review board of King Fahad Medical City (IRB Registration Number with KACST, KSA: H-01-R-012 and IRB Registration Number with OHRP/NIH, USA: IRB00010471). The requirement for informed consent was waived owing to the retrospective study design.
2.4. Statistical analysis
Categorical variables, such as gender, DM, HTN, DLP, smoker, CAD, HF SOB, etc. were presented as both numbers and percentages. Continuous variables, such as age, BMI, HR, RR, SBP, and DBP, were expressed as median [interquartile range]. The Kolmogorov–Smirnov test was used to confirm the assumption of normal distribution, and if the data was not normally distributed, nonparametric tests were used. Pearson’s chi-square test or Fisher’s exact test was used to determine significant associations between categorical variables, with Fisher’s exact test being used when expected cell frequencies were less than 5. The man-Whitney U test was applied to determine the significant difference between the type of TAVI and Pre and postechocardiography variables. A Wilcoxon signed-rank test was applied to determine the paired difference between Pre and post-procedure Echocardiography. A two-sided p-value less than 0.05 was considered statistically significant. All data were entered and analyzed using the SPSS 25 Statistics Package (SPSS Inc., Chicago, Illinois, USA).
3. Results
As shown in Tables 1 and 2, a total of 200 patients were included in the study. The mean age at diagnosis was 74.08 ± 9.87 years and the mean BMI was 29.34 ± 6.22 kg/m2. More than half of the participants were male (n = 111, 55.5 %). The majority of patients have comorbid conditions like diabetes mellitus (n = 150, 75 %), hypertension (n = 173, 86.5 %), and DLP (n = 145, 72.5 %). Nearly three-fourths of the participants (74.5 %, n = 149) were non-smokers and had no history of stroke/TIA (75.0 %, n = 150). Regarding shortness of breath, the majority of patients had NYHA Class 3 (40.5 %, n = 81). Dizziness or syncope was reported in 19.5 % (n = 39) of the patients, chest pain in 29.5 % (n = 59), and palpitation in 22.0 % (n = 44). The majority of the patients (76.5 %, n = 153) have severe AS, with a mean gradient of more than 40 mmHg. Most patients (63 %, n = 126) underwent TAVI with the Edwards Sapien system.
Table 1.
Clinical characteristics of patients at baseline
| Variables | Description | n (n%) |
|---|---|---|
| Gender | Male | 111 (55.5 %) |
| Female | 89 (44.5 %) | |
| Diabetes Mellitus | Yes | 150 (75.0 %) |
| No | 50 (25.0 %) | |
| Hypertension | Yes | 173 (86.5 %) |
| No | 27 (13.5 %) | |
| Dyslipidemia | Yes | 145 (72.5 %) |
| No | 55 (27.5 %) | |
| Smoker | Yes | 51 (25.5 %) |
| No | 149 (74.5 %) | |
| Coronary artery disease | Yes | 145 (72.5 %) |
| No | 55 (27.5 %) | |
| Heart failure | Yes | 108 (54.0 %) |
| No | 92 (46.0 %) | |
| Stroke/TIA | Yes | 50 (25.0 %) |
| No | 150 (75.0 %) | |
| Shortness of breath | NYHA class1 | 76 (38.0 %) |
| NYHA class 2 | 37 (18.5 %) | |
| NYHA class 3 | 81 (40.5 %) | |
| NYHA class 4 | 6 (3.0 %) | |
| Dizziness/Syncope | Yes | 39 (19.5 %) |
| No | 161 (80.5 %) | |
| Chest pain | Yes | 59 (29.5 %) |
| No | 141 (70.5 %) | |
| Palpitation | Yes | 44 (22.0 %) |
| No | 156 (78.0 %) | |
| Type of aortic stenosis | A mean gradient of more than 40 | 153 (76.5 %) |
| Low gradient low EF | 11 (5.5 %) | |
| Low gradient, normal EF | 36 (18.0 %) | |
| Aortic regurgitation | Normal | 118 (59.0 %) |
| Mild | 46 (23.0 %) | |
| Moderate | 30 (15.0 %) | |
| Severe | 6 (3.0 %) | |
| Mitral regurgitation | Normal | 135 (67.5%) |
| Mild | 35 (17.5%) | |
| Moderate | 25 (12.5%) | |
| Severe | 5 (2.5 %) | |
| Tricuspid regurgitation | Normal | 134 (67.0 %) |
| Mild | 35 (17.5 %) | |
| Moderate | 26 (13.0 %) | |
| Severe | 5 (2.5 %) | |
| Type of TAVI | Core vlve reveling system | 74 (37.0 %) |
| Edwards sapien system | 126 (63.0 %) | |
| Post-procedure Aortic regurgitation | Normal | 179 (89.5 %) |
| Mild | 20 (10.0 %) | |
| Moderate | 1 (0.5 %) | |
| Severe | 0 (0.0 %) | |
| Post-procedure mitral regurgitation | Normal | 129 (64.5 %) |
| Mild | 54 (27.0 %) | |
| Moderate | 9 (4.5 %) | |
| Severe | 8 (4.0 %) | |
| Post-procedure tricuspid regurgitation | Normal | 152 (76.0 %) |
| Mild | 33 (16.5 %) | |
| Moderate | 11 (5.5 %) | |
| Severe | 4 (2.0 %) |
Categorical data presented as frequencies (%).
Table 2.
Descriptive analysis of continuous physiological variables.
| Variables | Minimum | Maximum | Mean ± SD |
|---|---|---|---|
| Age | 45.00 | 100.00 | 74.08 ± 9.87 |
| Body mass index (BMI) | 16.00 | 49.00 | 29.34 ± 6.22 |
| Heart rate | 45.00 | 130.00 | 78.81 ± 15.83 |
| Respiratory rate | 16.00 | 30.00 | 21 ± 3.01 |
| Systolic BP | 90.00 | 177.00 | 124.36 ± 18.87 |
| Diastolic BP | 37.00 | 130.00 | 64.88 ± 11.09 |
| O2 Saturation | 87.00 | 100.00 | 95.52 ± 2.93 |
Table 3 shows the paired analysis of echocardiographic parameters before and after the procedure. Regarding LV mass, LVMi showed a significant decrease (p < 0.001). The left ventricular volumes represented by LVEDV, LVIDD, and LVEDS were found to have significant improvement (p < 0.001). Echocardiographic parameters before and after the procedure revealed statistically significant changes in nearly all the measures (p < 0.001) except for LAVi (p = 0.443).
Table 3.
Paired Analysis of echocardiographic parameters pre and post-TAVI procedure.
| Variables | Pre | Post | P value |
|---|---|---|---|
|
|
|
||
| Mean ± SD | Mean ± SD | ||
| LVIDD (mm) | 52.26 ± 5.09 | 47.6 ± 5.69 | <0.001* |
| LVIDS (mm) | 35.66 ± 6.09 | 30.02 ± 5.66 | <0.001* |
| LVEDV (ml) | 125.17 ± 30.97 | 103.65 ± 30.97 | <0.001* |
| LVEDS (ml) | 45.44 ± 18.17 | 32.95 ± 14.16 | <0.001* |
| LVEF | 63.27 ± 13.37 | 56.1 ± 16.31 | <0.001* |
| Stroke Volume Index | 42.27 ± 10.1 | 73.23 ± 12.74 | <0.001* |
| Aortic Peak PG | 75.61 ± 17.65 | 16.4 ± 8.11 | <0.001* |
| Aortic Mean PG | 48.55 ± 12.8 | 8.9 ± 4.76 | <0.001* |
| AVA | 0.7 ± 0.17 | 2.73 ± 0.69 | <0.001* |
| Aortic Annulus size | 28.44 ± 3.11 | 32.24 ± 4.4 | <0.001* |
| RV Basal Diameter (mm) | 35.93 ± 4.64 | 44.07 ± 5.61 | <0.001* |
| TAPSE | 2.5 ± 0.39 | 1.58 ± 0.54 | <0.001* |
| RVSP | 31.82 ± 12.49 | 36.13 ± 10.28 | <0.001* |
| LAVi | 37.14 ± 6.5 | 37.75 ± 8.36 | 0.443 |
| RAVi | 27.57 ± 3.39 | 37.38 ± 9.04 | <0.001* |
| LVMi | 92.91 ± 19.37 | 79.03 ± 14.91 | <0.001* |
| E/A | 0.93 ± 0.97 | 1.63 ± 0.34 | <0.001* |
| e′ | 6.57 ± 1.59 | 8.7 ± 2.04 | <0.001* |
| E/e | 19.22 ± 7.88 | 15.68 ± 2.73 | <0.001* |
Continuous data presented as Mean ± SD,
shows that the p-value is significant.
Paired Analysis given in Table 4, focuses on the patients with LVEF of less than 50%. Regarding LV mass, LVMi showed a significant decrease (p < 0.001). The LV volume, LVEDV, LVIDD, and LVEDS were found to have significantly improved (p < 0.001). Echocardiographic parameters before and after the procedure revealed statistically significant changes in nearly all the measures (p < 0.001) with the exception parameters of RVSP (p = 0.014), LAVi(0.301), E/e’ (0.041).
Table 4.
Paired Analysis of echocardigraphic parameters pre and post-TAVI procedure in patients with LVEF of <50%.
| Variables | Pre | Post | P value |
|---|---|---|---|
|
|
|
||
| Mean ± SD | Mean ± SD | ||
| LVIDD (mm) | 53.07 ± 5.2 | 47.8 ± 6.43 | <0.001* |
| LVIDS (mm) | 39.4 ± 6.72 | 32.9 ± 6.83 | <0.001* |
| LVEDV (ml) | 130.27 ± 46.24 | 110.1 ± 44.35 | <0.001* |
| LVEDS (ml) | 50.53 ± 33.05 | 33.63 ± 21.49 | <0.001* |
| LVEF | 43.31 ± 6.9 | 54.23 ± 16.01 | <0.001* |
| Stroke volume index | 43.4 ± 10.63 | 69.23 ± 12.84 | <0.001* |
| Aortic Peak PG | 74.27 ± 22.7 | 14.67 ± 8.38 | <0.001* |
| Aortic Mean PG | 43.83 ± 13.65 | 7.77 ± 4.5 | <0.001* |
| AVA | 0.68 ± 0.16 | 2.57 ± 0.57 | <0.001* |
| Aortic Annulus size | 28.17 ± 3.16 | 32.03 ± 3.61 | <0.001* |
| RV Basal Diameter (mm) | 35.63 ± 4.92 | 43 ± 5.56 | <0.001* |
| TAPSE | 2.45 ± 0.41 | 1.59 ± 0.61 | <0.001* |
| RVSP | 32.25 ± 13.23 | 39.45 ± 8.29 | 0.014* |
| LAVi | 36.9 ± 6.34 | 39.17 ± 8.53 | 0.301 |
| RAVi | 27.3 ± 3.45 | 38.5 ± 8.3 | <0.001* |
| LVMi | 90.37 ± 16.79 | 78.3 ± 13.35 | 0.002* |
| E/A | 0.96 ± 0.34 | 1.67 ± 0.3 | <0.001* |
| e′ | 6.62 ± 1.49 | 8.93 ± 2.08 | <0.001* |
| E/e′ | 18.64 ± 7.66 | 15.4 ± 2.67 | 0.041* |
Continuous data presented as Mean ± SD,
shows that the p-value is significant.
Table 5 presents the paired echocardiographic analysis for patients who had a pre-procedure LVEF of ≥50 %. Regarding LV mass, LVMi showed a significant decrease (p < 0.001). About LV volume represented by LVEDV and LVIDD, and LV size represented by LVIDD and LVEDS were found to have significantly improved (p < 0.001). The parameters of the right heart also showed significant improvement [PRE RV basal diameter (mm) 35.98 ± 4.6, post were 44.26 ± 5.62 (p-value <0.001), PRE RVSP 31.25 ± 12.42, post were 35.58 ± 10.5 (p-value <0.004)].
Table 5.
Paired Analysis of echocardiographic parameters pre and post-TAVI procedure in patients with LVEF of ≥50%.
| Variables | Pre | Post | P value |
|---|---|---|---|
|
|
|
||
| Mean ± SD | Mean ± SD | ||
| LVIDD (mm) | 52.12 ± 5.07 | 47.56 ± 5.57 | <0.001* |
| LVIDS (mm) | 35 ± 5.74 | 29.51 ± 5.29 | <0.001* |
| LVEDV (ml) | 124.26 ± 27.51 | 102.51 ± 27.99 | <0.001* |
| LVEDS (ml) | 44.54 ± 13.94 | 32.83 ± 12.5 | <0.001* |
| LVEF | 66.79 ± 10.92 | 56.42 ± 16.39 | <0.001* |
| Stroke volume index | 42.07 ± 10.03 | 73.93 ± 12.63 | <0.001* |
| Aortic Peak PG | 75.85 ± 16.67 | 16.71 ± 8.05 | <0.001* |
| Aortic Mean PG | 49.38 ± 12.51 | 9.09 ± 4.79 | <0.001* |
| AVA | 0.7 ± 0.17 | 2.75 ± 0.71 | <0.001* |
| Aortic Annulus size | 28.48 ± 3.1 | 32.27 ± 4.53 | <0.001* |
| RV Basal Diameter (mm) | 35.98 ± 4.6 | 44.26 ± 5.62 | <0.001* |
| TAPSE | 2.51 ± 0.38 | 1.58 ± 0.52 | <0.001* |
| RVSP | 31.75 ± 12.42 | 35.58 ± 10.5 | 0.004* |
| LAVi | 37.18 ± 6.55 | 37.5 ± 8.34 | 0.710 |
| RAVi | 27.61 ± 3.39 | 37.18 ± 9.18 | <0.001* |
| LVMi | 93.35 ± 19.8 | 79.16 ± 15.21 | <0.001* |
| E/A | 0.93 ± 1.04 | 1.62 ± 0.35 | <0.001* |
| e′ | 6.57 ± 1.61 | 8.66 ± 2.04 | <0.001* |
| E/e′ | 19.32 ± 7.94 | 15.72 ± 2.75 | <0.001* |
Continuous data presented as Mean ± SD,
shows that the p-value is significant.
4. Discussion
In our study paired echocardiographic analysis for patients who had a pre and post-procedure (TAVI), the Left ventricular mass index regressed from 130.7 (28.9) to 122.1 (28.9) g/m (P = 0.01). Maximum wall LV thickness decreased from 1.28 to 1.25 cm (P < 0.001) [13]. In comparison to another study, no significant change in LV end-systolic and end-diastolic diameters in pre in comparison to post-TAVI [13]. Our study showed that there are significant changes. Early outcomes resulted in the TAVI group, with a significant decrease in LV mass index and E/e′ short period after the procedure that persisted at 1 year [14]. Another study showed mean LV mass index was 113.4 ± 3.2 pre-TAVR and 106.1 ± 3.1 post-TAVR (p = 0.03) [15]. In our current study, it was reported that mean LVMi decreased significantly post-TAVI in both <50 and ≥50 LVEF groups. Another study showed LV systolic function changed and improved after TAVI in both groups (<50 and ≥ 50 LVEF) and a trend to decreased LV mass index in both LVEF groups. LV volumes changed and decreased significantly in those with low LVEF but not in those with preserved LVEF [22].
Moreover, in the current study, LVEF decreased significantly post-TAVI, and improvement was seen in the group with pre-TAVI <50 % groups. In the study by Sato et al.), LVEF improved only in patients with reduced baseline LVEF, TAVR also led to immediate improvement in LVEF (from 50.14 % to 53.13 %; P < 0.001) [23]. LVEDVi showed a small, but steady, rate of decrease after TAVR (P < 0.001). LVMi also showed a small, but rate of change and decrease during follow-up after TAVR (P < 0.001) [23].
In the present study, the mean age at diagnosis was 74.08 ± 9.87 years, with 55.5 % of patients being male. In comparison, a previous study reported a mean age of 79.1 ± 7.1 years, with 57 % male patients [11]. Additionally, the mean age of TAVI patients in another study was 79.75 ± 7.68 years [12].
In the current study, the repeated echo to compare between pre vs post-TAVI mean scores was 8.66 ± 5.69 months. For another study LV function and remodeling were investigated before TAVI and at 6 and 12 months after TAVI [11]. In our study, significant improvement and changes were observed in the post-TAVI End systolic volume (ESV), end-diastolic volume (EDV, and stroke volume (SV) as compared to pre-procedure. Conversely, an earlier study by Gruenig et al., reported that 6 months after TAVI there was a significant increase in EF (63 ± 39 %, p = 0.003). EDV, ESV, and SV did not change significantly at follow-up [16]. No significant change in LV end-systolic and end-diastolic diameters in pre in comparison to post-TAVI [13]. Our study showed that there are significant changes.
4.1. Study limitations
Since this was a retrospective study design and single-center study, limitations related to it such as selection bias. Moreover, since the post-TAVI tests were carried out on average after a year, the long-term impact of TAVI on LV was not determined.
4.2. Study strengths
The study provides a comprehensive echocardiographic analysis and also many variables were measured pre and post-TAVI.
4.3. Recommendations for future studies
Multi-center studies are needed to validate these findings and explore the long-term outcomes of TAVI. Patients with surgical valve replacement should also be studied in comparison to the TAVI procedure.
5. Conclusion
This study demonstrates that transcatheter aortic valve implantation (TAVI) leads to significant improvement in key echocardiographic parameters such as left ventricular (LV) size, functions, mass, and ejection fractions (EF).
Acknowledgments
The authors would like to thank the Research Center, King Fahad Medical City, Riyadh, Saudi Arabia for the tremendous support.
Abbreviations
- AS
Aortic Stenosis
- AVR
Aortic Valve Replacement
- AR
Aortic Regurgitation
- BMI
Body Mass Index
- CAD
Coronary Artery disease
- DBP
Diastolic blood pressure
- EF
Ejection Fractions
- HR
Heart Rate
- HF
Heart failure
- LV
Left Ventricular
- LVET
Left Ventricular Ejection Time
- LVEDP
Left Ventricular End-Diastolic Pressure
- LVIDd and LVIDs
Left Ventricular Internal Diameter End Diastole and End Systole
- LVEDV
Left Ventricular End diastolic Volume
- LVMi
Left ventricular Mass Index
- MR
Mitral Regurgitation
- PG
Mean Pressure Gradient
- RR
Respiratory Rate
- RV
Right Ventricular Basal Diameter
- RVSP
Right Ventricular Systolic Pressure
- RAVI
LAVI, Right, Left Atrial Volume Index
- SAVR
Surgical Aortic Valve Replacement
- SBP
Systolic blood Pressure
- SOB
Shortness of Breath
- TAVI
Transcatheter Aortic Valve Implantation
- TTE
Transthoracic Echocardiogram
- TEE
Transesophageal Echocardiogram
- TAPSE
Tricuspid Annular Plane Systolic Excursion
- TR
Tricuspid Regurgitation
- TIA
Transient Ischemic Attack
Footnotes
Funding: No funding was acquired for this research work.
Ethics statement: The studies involving human participants were reviewed and approved by KFMC-IRB. Written informed consent for participation was not required for this study per the national legislation and the institutional requirements.
Author contributions: Conception and design of Study: FTA, AAA. Literature review: FTA. Acquisition of data: FTA, MAS. Analysis and interpretation of data: FTA, AAA, MAS. Research investigation and analysis: FTA, AAA, MDA, KAM, AMA, MAS. Data collection: FTA, AAA, MDA, KAM, AMA, MAS. Drafting of manuscript: FTA. Revising and editing the manuscript critically for important intellectual contents: FTA, MAS. Data preparation and presentation: FTA, MAS. Supervision of the research: FTA, MAS. Research coordination and management: FTA, MAS. Funding for the research: FTA.
Conflict of interest: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Data availability statement
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
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Data Availability Statement
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.