Heart Team for Optimal Management of Patients with Severe Aortic Stenosis—Long-Term Outcomes and Quality of Life from Tertiary Cardiovascular Care Center
Abstract
:1. Introduction
2. Methods and Study Design
Statistical Analysis
3. Results
3.1. Study Population
3.2. Echocardiographic Parameters
3.3. Endpoints
3.4. Quality of Life
4. Discussion
5. Conclusions
6. Limitations
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Baseline Characteristic | Overall (482) | TAVR (318) | SAVR (85) | OMT (79) | p Value |
---|---|---|---|---|---|
Age, years; mean (SD) | 78.1 (7.9) | 79.0 (7.2) | 71.0 (6.2) | 81.7 (8.0) | <0.01 |
Gender, male (%) | 225 (46.7) | 149 (46.9) | 44 (51.8) | 32 (40.5) | 0.35 |
BMI, kg/m2; mean (SD) | 27.8 (4.9) | 28.2 (4.8) | 27.9 (3.9) | 26.4 (5.9) | 0.01 |
Heart Failure, n (%) | 400 (83.0) | 279 (87.7) | 50 (58.8) | 71 (89.9) | <0.01 |
NYHA, mean (SD) | 2.35 (0.79) | 2.28 (0.71) | 2.17 (0.77) | 2.84 (0.93) | <0.01 |
CAD, n (%) | 284 (58.9) | 188 (51.9) | 39 (45.9) | 57 (72.2) | <0.01 |
Diabetes, n (%) | 176 (36.5) | 120 (37.7) | 23 (27.1) | 33 (41.8) | 0.11 |
Hypertension, n (%) | 417 (86.5) | 276 (86.8) | 72 (84.7) | 69 (87.3) | 0.86 |
Previous stroke/TIA, n (%) | 47 (9.8) | 30 (9.4) | 4 (4.7) | 13 (16.5) | 0.04 |
Atrial fibrillation, n (%) | 171 (35.5) | 122 (38.4) | 19 (22.4) | 30 (38.0) | 0.02 |
Previous MI, n (%) | 99 (20.5) | 49 (15.4) | 13 (15.3) | 37 (46.8) | <0.01 |
Previous PCI, n (%) | 246 (51.0) | 167 (52.5) | 30 (35.3) | 49 (62.0) | <0.01 |
Previous CABG, n (%) | 53 (11.0) | 29 (9.1) | 10 (11.8) | 14 (17.7) | 0.09 |
Previous non-aortic VS, n (%) | 25 (5.2) | 14 (4.4) | 3 (3.5) | 8 (10.1) | 0.09 |
History of pacemaker, n (%) | 71 (14.7) | 57 (17.9) | 1 (1.2) | 13 (16.5) | <0.01 |
≥Moderate MR, n (%) | 26 (5.4) | 11 (3.5) | 3 (3.5) | 12 (15.2) | <0.01 |
≥Moderate TR, n (%) | 26 (5.4) | 14 (4.4) | 1 (1.2) | 11 (13.9) | <0.01 |
PAD, n (%) | 86 (17.8) | 48 (15.1) | 9 (10.6) | 29 (36.7) | <0.01 |
CKD, n (%) | 303 (62.9) | 223 (70.1) | 31 (36.5) | 49 (62.0) | <0.01 |
Anemia, n (%) | 289 (60.0) | 206 (64.8) | 25 (29.4) | 58 (73.4) | <0.01 |
Dyslipidemia, n (%) | 371 (77.0) | 248 (78.0) | 64 (75.2) | 59 (74.7) | 0.76 |
COPD, n (%) | 72 (14.9) | 42 (13.2) | 6 (7.1) | 24 (30.4) | <0.01 |
Severe PH, n (%) | 46 (9.5) | 21 (6.6) | 3 (3.5) | 22 (27.8) | <0.01 |
Cancer, n (%) | 69 (14.3) | 39 (12.3) | 9 (10.6) | 21 (26.6) | <0.01 |
Smoking, n (%) | 323 (67.0) | 216 (67.9) | 53 (62.4) | 54 (68.4) | 0.6 |
Frailty, n (%) | 221 (45.9) | 151 (47.5) | 11 (12.9) | 59 (74.7) | <0.01 |
EuroSCORE II, %; mean (SD) | 9.3 (9.7) | 9.7 (11.0) | 5.7 (4.0) | 11.4 (7.3) | <0.01 |
STS score, %; mean (SD) | 5.9 (2.0) | 6.0 (2.1) | 3.6 (1.7) | 7.1 (2.6) | <0.01 |
Baseline | At Discharge | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Echocardiographic Parameter | Overall (483) | TAVR (318) | SAVR (85) | OMT | p Value | Overall (377) | TAVR (298) | SAVR (79) | OMT (79) | p Value |
LVEF, %; mean (SD) | 52.5 (13.4) | 54.2 (12.5) | 56.5 (12.1) | 41.6 (12.5) | <0.01 | 55.9 (10.6) | 55.4 (10.9) | 57.3 (9.9) | - | 0.2 |
LVEDD, cm; mean (SD) | 5.3 (0.78) | 5.2 (0.76) | 5.3 (0.82) | 5.4 (0.79) | 0.16 | 5.2 (0.80) | 5.2 (0.78) | 5.0 (0.85) | - | 0.03 |
LVESD, cm; mean (SD) | 3.2 (0.79) | 3.2 (0.77) | 3.2 (0.81) | 3.3 (0.82) | 0.63 | 3.2 (0.76) | 3.2 (0.76) | 3.2 (0.78) | - | 0.76 |
IVSD, cm; mean (SD) | 1.36 (0.18) | 1.35 (0.18) | 1.39 (0.16) | 1.33 (0.19) | 0.11 | 1.33 (0.17) | 1.33 (0.18) | 1.34 (0.16) | - | 0.76 |
AVA, cm2; mean (SD) | 0.78 (0.15) | 0.79 (0.16) | 0.76 (0.14) | 0.77 (0.13) | 0.25 | 1.78 (0.40) | 1.77 (0.41) | 1.82 (0.37) | - | 0.44 |
AVA I, cm2/m2; mean (SD) | 0.47 (0.18) | 0.45 (0.16) | 0.49 (0.18) | 0.53 (0.20) | <0.01 | 0.97 (0.24) | 0.96 (0.25) | 0.99 (0.18) | - | 0.51 |
PAV, m/s; mean (SD) | 4.38 (0.94) | 4.34 (0.94) | 4.59 (0.97) | 4.32 (0.91) | 0.07 | 2.23 (0.79) | 2.27 (0.74) | 2.16 (0.89) | - | 0.19 |
DVI; mean (SD) | 0.20 (0.05) | 0.20 (0.05) | 0.21 (0.04) | 0.20 (0.06) | 0.39 | 0.41 (0.09) | 0.40 (0.09) | 0.45 (0.08) | - | <0.01 |
Peak AVG, mmHg; mean (SD) | 68.6 (24.5) | 69.2 (26.4) | 70.3 (20.7) | 64.2 (19.6) | 0.21 | 20.3 (7.6) | 21.2 (7.4) | 17.3 (7.5) | - | <0.01 |
Mean AVG, mmHg; mean (SD) | 42.6 (16.3) | 42.3 (16.4) | 45.4 (12.6) | 41.0 (19.2) | 0.18 | 12.4 (6.0) | 12.7 (6.0) | 11.3 (5.7) | - | 0.07 |
Bicuspid valve, n (%) | 40 (8.3) | 20 (6.3) | 13 (15.3) | 7 (8.9) | 0.03 | - | - | - | - | - |
≥Moderate PVAR, n/all (%) | - | - | - | - | - | 5 (1.3) | 5 (1.7) | 0 (0.0) | - | 0.25 |
≥Moderate total AR, n/all (%) | - | - | - | - | - | 9 (2.4) | 8 (2.7) | 1 (1.3) | - | 0.46 |
Endpoints | TAVR (318) | SAVR (85) | OMT (79) | p Value Overall | TAVR vs. SAVR HR [95% CI]; p | SAVR vs. OMT HR [95% CI]; p | TAVR vs. OMT HR [95% CI]; p |
---|---|---|---|---|---|---|---|
Primary Endpoint, n (%) | 110 (34.6) | 28 (32.9) | 75 (94.9) | <0.01 | 1.05 [0.73–1.51]; 0.78 | 0.35 [0.22–0.55]; < 0.01 | 0.36 [0.25–0.53]; <0.01 |
Secondary Endpoints, n (%) | |||||||
All-cause mortality | 50 (15.7) | 14 (16.5) | 29 (36.7) | <0.01 | 0.95 [0.55–1.65]; 0.88 | 0.45 [0.22–0.90]; <0.01 | 0.43 [0.24–0.75]; <0.01 |
Non-fatal strokes | 18 (5.7) | 7 (8.2) | 11 (13.9) | 0.04 | 0.69 [0.29–1.65]; 0.38 | 0.59 [0.19–1.81]; 0.25 | 0.41 [0.17–1.00]; 0.01 |
Non-fatal disabling strokes | 9 (2.8) | 4 (4.7) | 8 (10.1) | 0.02 | 0.60 [0.19–1.89]; 0.39 | 0.46 [0.11–2.02]; 0.19 | 0.28 [0.09–0.91]; <0.01 |
CV death | 36 (11.3) | 9 (10.6) | 19 (24.1) | <0.01 | 1.07 [0.55–2.06]; 0.85 | 0.44 [0.19–1.02]; 0.02 | 0.47 [0.24–0.93]; <0.01 |
Non-fatal MI | 9 (2.8) | 3 (3.5) | 8 (10.1) | 0.01 | 0.80 [0.25–2.60]; 0.74 | 0.35 [0.08–1.57]; 0.09 | 0.28 [0.08–0.94]; <0.01 |
AKI (30 days) | 9 (2.8) | 12 (14.1) | - | - | 0.20 [0.07–0.57]; <0.01 | - | - |
New onset AF (30 days) | 24 (7.5) | 13 (15.3) | 2 (2.5) | <0.01 | 0.49 [0.21–1.14]; 0.03 | 6.04 [2.06–17.73]; <0.01 | 2.98 [1.25–7.09]; 0.11 |
New onset AF (EOF) | 38 (11.9) | 19 (22.4) | 10 (12.7) | 0.05 | 0.53 [0.28–1.02]; 0.01 | 1.77 [0.78–4.02]; 0.11 | 0.94 [0.49–1.83]; 0.86 |
Major bleeding (30 days) | 19 (6.0) | 11 (12.9) | - | - | 0.46 [0.19–1.11]; 0.02 | - | - |
Major bleeding (EOF) | 36 (11.3) | 17 (20.0) | 1 (1.3) | <0.01 | 0.57 [0.28–1.16]; 0.04 | 15.80 [6.33–39.45]; <0.01 | 8.94 [4.28–18.67]; <0.01 |
Major vascular complications (30 days) | 32 (10.06) | 2 (2.35) | - | - | 4.28 [2.21–8.29]; 0.02 | - | - |
Infective valve endocarditis (30 days) | 5 (1.6) | 1 (1.2) | - | - | 1.33 [0.19–9.50]; 0.79 | - | - |
Infective valve endocarditis (EOF) | 8 (2.5) | 3 (3.5) | 3 (3.8) | 0.78 | 0.71 [0.18–2.90]; 0.61 | 0.93 [0.15–5.61]; 0.93 | 0.66 [0.16–2.81]; 0.54 |
Permanent pacemaker implantation (30 days) | 53 (16.7) | 6 (7.1) | - | - | 2.36 [1.26–4.41]; 0.03 | - | - |
Permanent pacemaker implantation (EOF) | 72 (22.6) | 9 (10.6) | 6 (7.6) | 0.01 | 2.14 [1.22–3.76]; 0.01 | 1.39 [0.68–2.87]; 0.51 | 2.98 [1.67–5.32]; <0.01 |
Aortic valve re-interventions (EOF) | 6 (1.9) | 2 (2.4) | - | - | 0.80 [0.15–4.38]; 0.78 | - | - |
Non-fatal rehospitalizations for AS (EOF) | 51 (16.0) | 10 (11.8) | 38 (48.1) | <0.01 | 1.36 [0.80–2.31]; 0.33 | 0.24 [0.12–0.48]; <0.01 | 0.33 [0.19–0.57]; <0.01 |
In-hospital mortality | 20 (6.3) | 6 (7.1) | - | - | 0.89 [0.35–2.29]; 0.8 | - | - |
ICU stay, days (SD) | 1.8 (3.8) | 4.2 (3.7) | - | - | <0.01 | - | - |
TAVR (318/268) | SAVR (85/71) | OMT (79/50) | p-Value | |
---|---|---|---|---|
Physical Component Summary (PCS) | ||||
Before SAVR, TAVR, HT disscusion; mean (SD) | 81.5 (14.4) | 79.2 (16.5) | 83.1 (13.0) | 0.22 |
After SAVR, TAVR, HT disscusion—at the end of follow up; mean (SD) | 69.5 (13.9) | 65.7 (16.1) | 84.1 (12.5) | <0.01 |
Mental Component Summary (MCS) | ||||
Before SAVR, TAVR, HT disscusion; mean (SD) | 52.9 (8.6) | 52.1 (9.8) | 53.8 (7.8) | 0.46 |
After SAVR, TAVR, HT disscusion—at the end of follow up; mean (SD) | 41.4 (8.3) | 39.1 (9.2) | 56.5 (8.0) | <0.01 |
Total | ||||
Before SAVR, TAVR, HT disscusion; mean (SD) | 134.5 (17.5) | 131.3 (20.2) | 136.9 (13.8) | 0.12 |
After SAVR, TAVR, HT disscusion—at the end of follow up; mean (SD) | 111.0 (16.9) | 104.8 (21.0) | 140.6 (13.5) | <0.01 |
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Jonik, S.; Marchel, M.; Pędzich-Placha, E.; Huczek, Z.; Kochman, J.; Ścisło, P.; Czub, P.; Wilimski, R.; Hendzel, P.; Opolski, G.; et al. Heart Team for Optimal Management of Patients with Severe Aortic Stenosis—Long-Term Outcomes and Quality of Life from Tertiary Cardiovascular Care Center. J. Clin. Med. 2021, 10, 5408. https://doi.org/10.3390/jcm10225408
Jonik S, Marchel M, Pędzich-Placha E, Huczek Z, Kochman J, Ścisło P, Czub P, Wilimski R, Hendzel P, Opolski G, et al. Heart Team for Optimal Management of Patients with Severe Aortic Stenosis—Long-Term Outcomes and Quality of Life from Tertiary Cardiovascular Care Center. Journal of Clinical Medicine. 2021; 10(22):5408. https://doi.org/10.3390/jcm10225408
Chicago/Turabian StyleJonik, Szymon, Michał Marchel, Ewa Pędzich-Placha, Zenon Huczek, Janusz Kochman, Piotr Ścisło, Paweł Czub, Radosław Wilimski, Piotr Hendzel, Grzegorz Opolski, and et al. 2021. "Heart Team for Optimal Management of Patients with Severe Aortic Stenosis—Long-Term Outcomes and Quality of Life from Tertiary Cardiovascular Care Center" Journal of Clinical Medicine 10, no. 22: 5408. https://doi.org/10.3390/jcm10225408
APA StyleJonik, S., Marchel, M., Pędzich-Placha, E., Huczek, Z., Kochman, J., Ścisło, P., Czub, P., Wilimski, R., Hendzel, P., Opolski, G., Grabowski, M., & Mazurek, T. (2021). Heart Team for Optimal Management of Patients with Severe Aortic Stenosis—Long-Term Outcomes and Quality of Life from Tertiary Cardiovascular Care Center. Journal of Clinical Medicine, 10(22), 5408. https://doi.org/10.3390/jcm10225408