Sutureless and Rapid Deployment vs. Transcatheter Valves for Aortic Stenosis in Low-Risk Patients: Mid-Term Results
Abstract
:1. Introduction
2. Materials and Methods
2.1. Sutureless and Rapid Deployment Aortic Valves (SuRD-AVR)
2.2. Transcatheter Aortic Valve Implantation (TAVI)
2.3. Statistical Analysis
2.4. Study Endpoints and Definitions
3. Results
3.1. Operative Outcomes
3.2. Postoperative Results
3.3. Mid-Term Outcomes
4. Discussion
Study Limitations
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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UNMATCHED | MATCHED | |||||
---|---|---|---|---|---|---|
SuRD-AVR (n = 636) | TAVI (n = 670) | p-Value | SuRD-AVR (n = 346) | TAVI (n = 346) | p-Value | |
Age (years), median (IQR) | 78 (74–81) | 81 (77–84) | <0.001 | 79 (76–83) | 80 (76–84) | 0.266 |
Gender (female) | 364 (57.2%) | 312 (46.6%) | <0.001 | 186 (53.8%) | 189 (54.6%) | 0.819 |
Body mass index (kg/m2) | 27.1 ± 4.6 | 27.2 ± 4.3 | 0.642 | 26.9 ± 4.7 | 27.2 ± 4.9 | 0.069 |
Body surface area (m2), median (IQR) | 1.81 ± 0.2 | 1.82 ± 0.2 | 0.773 | 1.81 ± 0.2 | 1.81 ± 0.2 | 0.923 |
EuroSCORE II (%), median (IQR) | 2.0 (1.4–2.8) | 3.0 (2.3–3.5) | <0.001 | 2.6 (1.9–3.2) | 2.5 (2.0–3.1) | 0.977 |
Hypertension(mmHg) | 532 (83.6%) | 566 (84.5%) | 0.682 | 282 (81.5%) | 291 (84.1%) | 0.365 |
Dyslipidaemia | 428 (67.3%) | 359 (53.6%) | <0.001 | 196 (56.6%) | 195 (56.4%) | 0.939 |
Diabetes Mellitus | 208 (32.7%) | 141 (21.0%) | <0.001 | 92 (26.6%) | 83 (24.0%) | 0.431 |
Advance NYHA (class III–IV) | 253 (39.8%) | 257 (38.4%) | 0.598 | 79 (22.8%) | 82 (23.7%) | 0.787 |
COPD (FEV1 < 60%) | 69 (10.8%) | 93 (13.9%) | 0.097 | 46 (13.3%) | 49 (14.2%) | 0.740 |
Previous CVA | 50 (7.9%) | 45 (6.7%) | 0.426 | 21 (6.1%) | 16 (4.6%) | 0.398 |
Atrial fibrillation | 63 (9.9%) | 63 (9.4%) | 0.758 | 36 (10.4%) | 30 (8.7%) | 0.437 |
Pulmonary hypertension (>30 mmHg) | 179 (28.1%) | 228 (34%) | 0.022 | 114 (32.9%) | 112 (32.4%) | 0.871 |
Peripherical arterial disease | 68 (10.7%) | 67 (10%) | 0.681 | 35 (10.1%) | 31 (9.0%) | 0.604 |
Previous Cardiac Surgery | 12 (1.9%) | 152 (22.7%) | <0.001 | 12 (3.5%) | 17 (4.9%) | 0.343 |
Frailty | 19 (2.9%) | 33 (4.9%) | 0.073 | 10 (2.8%) | 15 (4.3%) | 0.308 |
Creatinine (mg/dL), mean ± SD | 0.95 ± 0.5 | 1.15 ± 0.6 | <0.001 | 1.01 ± 0.7 | 1.06 ± 0.6 | 0.324 |
Sievers Type 1 Bicupid valve | 44 (6.7%) | 7 (1%) | <0.001 | 6 (1.7%) | 5 (1.4%) | 0.761 |
SAA | 111 (17.4%) | 139 (20.7%) | 0.130 | 67 (19.3%) | 86 (24.8%) | 0.081 |
Left ventricular ejection fraction, mean ± SD | 57.7 ± 6 | 57.7 ± 7 | 0.478 | 57.6 ± 6 | 56.4 ± 7 | 0.231 |
UNMATCHED | MATCHED | |||||
---|---|---|---|---|---|---|
SuRD-AVR (n = 636) | TAVI (n = 670) | p-Value | SuRD-AVR (n = 346) | TAVI (n = 346) | p-Value | |
Sternotomy, n (%) | 230 (36.2%) | 141 (40.8%) | ||||
MICS, n (%) | 406 (63.8%) | 205 (59.2%) | ||||
CPB time(min), median (IQR) | 62 (51–83) | 63 (49–84) | ||||
Aortic cross-clamp time (min), median (IQR) | 42 (32–55) | 39 (30–54) | ||||
TF-TAVI, n (%) | 569 (84.9%) | 304 (87.9%) | ||||
TV-TAVI, n (%) | 87 (13%) | 34 (9.8%) | ||||
TA-TAVI, n (%) | 14 (2.1%) | 8 (2.3%) | ||||
Valve size (mm), median (IQR) | 23 (23–25) | 26 (23–26) | <0.001 | 23 (23–25) | 26 (23–26) | <0.001 |
Non-elective procedure, n (%) | 6 (0.94%) | 7 (1.04%) | 0.853 | 3 (0.86%) | 5 (1.45%) | 0.721 |
ICU stay(days), median (IQR) | 1 (0–1.5) | 1 (0–2) | 0.258 | 1 (0–2) | 1 (0–2) | 0.672 |
ECHO at discharge | ||||||
Postoperative EF% | 50 (49–60) | 50 (50–55) | 0.653 | 50 (50–60) | 50 (47–56) | 0.583 |
Mean transvalvular gradient (mmHg), mean ± SD | 10.2 ± 5.1 | 10.7 ± 4.7 | 0.452 | 10.6 ± 4.8 | 10.8 ± 5.1 | 0.765 |
EOA (cm2), mean ± SD | 1.7 ± 0.4 | 1.6 ± 0.5 | 0.379 | 1.8 ± 0.4 | 1.8 ± 0.5 | 0.830 |
PVL > 2 | 7 (1.1%) | 23 (3.4%) | 0.005 | 4 (1.2%) | 14 (4.1%) | 0.029 |
UNMATCHED | MATCHED | |||||
---|---|---|---|---|---|---|
Surgery (n = 636) | TAVR (n = 670) | p-Value | Surgery (n = 346) | TAVR (n = 346) | p-Value | |
Procedural Mortality | 2 (0.31%) | 4 (0.60%) | 0.450 | 1 (0.29%) | 1 (0.29%) | 1.000 |
30-Days Mortality | 13 (2.04%) | 19 (2.84%) | 0.355 | 6 (1.73%) | 7 (2.02%) | 0.779 |
Cardiac Death | 5 (0.9%) | 8 (1.2%) | 0.837 | 3 (0.87%) | 4 (1.16%) | 1.000 |
PPI | 51 (8.0%) | 95 (14.2%) | <0.001 | 23 (6.7%) | 38 (10.9%) | 0.044 |
Surgical revision for bleeding | 28 (4.4%) | 6 (0.9%) | <0.001 | 21 (6.1%) | 2 (0.6%) | <0.001 |
Blood Transfusion | 93 (14.6%) | 25 (3.7%) | <0.001 | 51 (14.7%) | 7 (2.0%) | <0.001 |
Atrial Fibrillation | 44 (6.9%) | 167 (24.9%) | <0.001 | 21 (6.0%) | 76 (21.9%) | <0.001 |
Acute renal failure | 26 (4.08%) | 17 (2.54%) | 0.117 | 14 (4.05%) | 9 (2.60%) | 0.289 |
Stroke | 4 (0.63%) | 9 (1.34%) | 0.267 | 3 (0.87%) | 5 (1.47%) | 0.725 |
Endocarditis | 3 (0.47%) | 4 (0.60%) | 1 | 2 (0.7%) | 3 (0.9%) | 0.784 |
Vascular complication | 4 (0.63%) | 29 (4.33%) | 0.001 | 3 (0.9%) | 17 (4.9%) | 0.001 |
UNIVARIABLE | MULTIVARIABLE | |||||
---|---|---|---|---|---|---|
HR | 95% CI | p-Value | HR | 95% CI | p-Value | |
PPI (TVC) | 1.87 | 1.14–3.06 | 0.012 | 1.82 | 1.11–2.99 | <0.001 |
PVL (TVC) | 0.29 | 0.04–2.14 | 0.230 | |||
SAA | 1.06 | 0.64–1.73 | 0.814 | |||
TAVI vs. SuRD-AVR | 1.53 | 1.02–2.03 | 0.040 | 1.74 | 1.12–2.71 | 0.013 |
PAPs > 30 mmHg | 1.06 | 0.69–1.64 | 0.771 | |||
LVEF < 35% | 0.81 | 0.19–3.35 | 0.780 | |||
III stage CKD | 3.39 | 1.67–6.89 | <0.001 | 3.45 | 1.70–7.01 | <0.001 |
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Muneretto, C.; Di Bacco, L.; Di Eusanio, M.; Folliguet, T.; Rosati, F.; D’Alonzo, M.; Cugola, D.; Curello, S.; Palacios, C.M.; Baudo, M.; et al. Sutureless and Rapid Deployment vs. Transcatheter Valves for Aortic Stenosis in Low-Risk Patients: Mid-Term Results. J. Clin. Med. 2023, 12, 4045. https://doi.org/10.3390/jcm12124045
Muneretto C, Di Bacco L, Di Eusanio M, Folliguet T, Rosati F, D’Alonzo M, Cugola D, Curello S, Palacios CM, Baudo M, et al. Sutureless and Rapid Deployment vs. Transcatheter Valves for Aortic Stenosis in Low-Risk Patients: Mid-Term Results. Journal of Clinical Medicine. 2023; 12(12):4045. https://doi.org/10.3390/jcm12124045
Chicago/Turabian StyleMuneretto, Claudio, Lorenzo Di Bacco, Marco Di Eusanio, Thierry Folliguet, Fabrizio Rosati, Michele D’Alonzo, Diego Cugola, Salvatore Curello, Camila Mayorga Palacios, Massimo Baudo, and et al. 2023. "Sutureless and Rapid Deployment vs. Transcatheter Valves for Aortic Stenosis in Low-Risk Patients: Mid-Term Results" Journal of Clinical Medicine 12, no. 12: 4045. https://doi.org/10.3390/jcm12124045
APA StyleMuneretto, C., Di Bacco, L., Di Eusanio, M., Folliguet, T., Rosati, F., D’Alonzo, M., Cugola, D., Curello, S., Palacios, C. M., Baudo, M., Pollari, F., & Fischlein, T. (2023). Sutureless and Rapid Deployment vs. Transcatheter Valves for Aortic Stenosis in Low-Risk Patients: Mid-Term Results. Journal of Clinical Medicine, 12(12), 4045. https://doi.org/10.3390/jcm12124045