Non-Inferiority of Sutureless Aortic Valve Replacement in the TAVR Era: David versus Goliath
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Populations
2.2. Study Groups
2.3. Operative Techniques
2.4. Outcomes and Definitions
2.5. Statistical Analysis
3. Results
3.1. Baseline Characteristics
3.2. Intraoperative Characteristics
3.3. Postoperative Characteristics and Survival
3.4. Figures and Tables
4. Discussion
- SU-AVR is a feasible and safe treatment option that presents itself as at least a non-inferior alternative to TA-TAVR in intermediate-risk patients.
- Both treatments offer a high technical procedural success, nonetheless, SU-AVR offers significantly longer operating times with no negative effect on the length of stay at the intensive care unit and ventilation time.
- Both treatment options present no significant difference in postoperative pacemaker implantation and stroke.
- Despite the use of contrast medium in the TA-TAVI group, there was no significant difference in postoperative new onset dialysis rate and maximum creatinine levels when compared to SU-AVR.
- Patients from the surgical arm needed significantly more intraoperative blood transfusions.
- There was no significant difference in the hemodynamic performance of the valve prostheses between the groups. Both methods provided low postoperative transvalvular gradients with no increased risk of paravalvular leakage in both groups.
- There was no significant difference in 30-day and 6-month mortality.
5. Conclusions
Study Limitations
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Characteristics | All Patients (n = 112) | TA-TAVR (n = 56) | SURD-AVR (n = 56) | p-Value |
---|---|---|---|---|
female sex | 27 (24.1%) | 14 (25%) | 13 (23.2%) | 0.825 |
age, years | 71.6 ± 8.2 | 74.3 ± 7.8 | 69.05 ± 7.9 | 0.001 |
BMI, kg/qcm | 28.8 ± 6.5 | 28.8 ± 7.6 | 28.8 ± 5.4 | 0.322 |
arterial hypertension | 106 (94.6%) | 52 (92.9%) | 54 (96.4%) | 0.401 |
pulmonary hypertension | 10 (8.9%) | 4 (7.1%) | 6 (10.7%) | 0.508 |
hyperlipidemia | 61 (54.5%) | 28 (50.0%) | 33 (58.9%) | 0.343 |
renal insufficiency | 30 (26.8%) | 17 (30.4%) | 13 (23.2%) | 0.393 |
previous MI | 23 (20.5%) | 15 (26.8%) | 8 (14.3%) | 0.101 |
COPD | 26 (23.2%) | 15 (26.8%) | 11 (19.6%) | 0.371 |
CAD | 85 (75.9%) | 42 (75.0%) | 43 (76.8%) | 0.825 |
PAD | 38 (33.9%) | 29 (51.8%) | 9 (16.1%) | <0.001 |
NYHA Class | ||||
I | 18 (16.1%) | 14 (25%) | 4 (7.1%) | 0.01 |
II | 54 (48.2%) | 21 (37.5%) | 33 (58.9%) | 0.023 |
III | 41 (36.6%) | 21 (37.5%) | 20 (35.7%) | 0.844 |
creatinine, mg/dL | 1.4 ± 1.3 | 1.4 ± 1.1 | 1.4 ± 1.4 | 0.4 |
bilirubine, mg/dL | 0.7 ± 0.6 | 0.6 ± 0.4 | 0.76 ± 0.8 | 0.79 |
diabetes mellitus type 2 | 39 (34.8%) | 20 (35.7%) | 19 (33.9%) | 0.843 |
dialysis | 9 (8%) | 5 (8.9%) | 4 (7.1%) | 1.0 |
EF, % | 51.6 ± 9.5 | 51.9 ± 9.3 | 51.2 ± 9.9 | 0.676 |
AS > II | 108 (96.4%) | 56 (100%) | 52 (92.9%) | 0.042 |
AR > II | 10 (8.9%) | 0 | 10 (17.9%) | 0.001 |
logistic EuroSCORE I | 6.9 (IQR 3.6–13.0) | 8.0 (IQR 4.5–13.0) | 5.4 (IQR 2.9–13.2) | 0.18 |
EuroSCORE II | 3.1 (IQR 1.9–5.3) | 3.2 (IQR 2.3–5.4) | 2.8 (IQR 1.5–5.2) | 0.112 |
Characteristics | All Patients (n = 112) | TA-TAVR (n = 56) | SURD-AVR (n = 56) | p-Value |
---|---|---|---|---|
elective | 87 (77.7%) | 45 (80.4%) | 42 (75.0%) | 0.496 |
urgent | 21 (18.8%) | 10 (17.9%) | 11 (19.6%) | 0.809 |
emergent | 3 (2.7%) | 1 (1.8%) | 2 (3.6%) | 1.0 |
redo | 6 (5.4%) | 1 (1.8%) | 5 (8.9%) | 0.206 |
concomitant procedure | 36 (32.1%) | - | 36 (64.3%) | - |
CABG | 34 (30.4%) | - | 34 (60.7%) | - |
MAZE | 3 (2.7%) | - | 3 (5.4%) | - |
PFO closure | 2 (1.8%) | - | 2 (3.6%) | - |
operating time, min | 108.2 ± 58.6 | 67.3 ± 34.7 | 149.05 ± 48.3 | <0.001 |
cross-clamp time, min | 9.0 (IQR 0.0–47.0) | - | 49.4 ± 17.4 | - |
blood transfusion | 37 (33.0%) | 6 (10.7%) | 31 (55.4%) | <0.001 |
Erythrocytes, Units | 0.0 (IQR 0.0–2.0) | 0.0 (IQR 0.0–0.0) | 1.0 (IQR 0.0–2.0) | <0.001 |
Perceval | ||||
S | 8 (7.1%) | - | 8 (14.3%) | - |
M | 11 (9.8%) | - | 11 (19.6%) | - |
L | 16 (14.3%) | - | 16 (28.6%) | - |
XL | 22 (19.6%) | - | 22 (39.2%) | - |
Sapien | ||||
23 | 18 (16.1%) | 18 (32.2%) | - | - |
26 | 28 (25%) | 28 (50.0%) | - | - |
29 | 9 (8%) | 9 (16%) | - | - |
contrast dye, ml | - | 75 (IQR 50.0–93.75) | - | - |
Characteristics | All Patients (n = 112) | TA-TAVR (n = 56) | SURD-AVR (n = 56) | p-Value |
---|---|---|---|---|
stroke | 1 (0.9%) | 1 (1.8%) | 0 | 1.0 |
maximal creatinine, mg/dl | 1.23 (IQR 1.0–1.9) | 1.2 (IQR 1.0–1.8) | 1.25 (IQR 0.9–1.9) | 0.86 |
maximal biliribine, mg/dl | 0.85 (IQR 0.6–1.3) | 0.8 (IQR 0.6–1.2) | 0.9 (IQR 0.7–1.7) | 0.07 |
pacemaker implantation | 1 (0.9%) | 1 (1.8%) | 0 | 1.0 |
new dialysis | 8 (7.1%) | 3 (5.4%) | 5 (8.9%) | 0.72 |
mechanical ventilation, days | 1.0 (IQR 1.0–1.0) | 1.0 (IQR 1.0–1.0) | 1.0 (IQR 1.0–1.75) | 0.42 |
re-intubation | 1 (0.9%) | 0 | 1 (1.8%) | 1.0 |
Low output syndrome | 4 (3.6%) | 1 (1.8%) | 3 (5.4%) | 0.61 |
AR at discharge | 0 | 0 | 0 | - |
re-thoracotomy | 6 (5.4%) | 0 | 6 (10.7%) | 0.027 |
wound infection | 3 (2.7%) | 0 | 3 (5.4%) | 0.243 |
postoperative MPG, mmHg | 5.7 ± 1.7 | 5.0 (IQR 4.0–6.0) | 6.0 (IQR 4.25–7.0) | 0.125 |
hospital LOS, days | 8.9 ± 4.5 | 8.2 ± 3.4 | 9.7 ± 5.3 | 0.25 |
ICU LOS, days | 2.0 (IQR 1.0–4.0) | 2.0 (IQR 2.0–4.0) | 2.0 (IQR 1.0–3.75) | 0.39 |
follow-up, months | 18.1 ± 12.3 | 25.1 ± 12.8 | 11.0 ± 6.2 | <0.001 |
30-day mortality | 1 (0.9%) | 0 | 1 (1.8%) | 1.0 |
6-month mortality | 1 (0.9%) | 0 | 1 (1.8%) | 1.0 |
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Zubarevich, A.; Szczechowicz, M.; Amanov, L.; Arjomandi Rad, A.; Osswald, A.; Torabi, S.; Ruhparwar, A.; Weymann, A. Non-Inferiority of Sutureless Aortic Valve Replacement in the TAVR Era: David versus Goliath. Life 2022, 12, 979. https://doi.org/10.3390/life12070979
Zubarevich A, Szczechowicz M, Amanov L, Arjomandi Rad A, Osswald A, Torabi S, Ruhparwar A, Weymann A. Non-Inferiority of Sutureless Aortic Valve Replacement in the TAVR Era: David versus Goliath. Life. 2022; 12(7):979. https://doi.org/10.3390/life12070979
Chicago/Turabian StyleZubarevich, Alina, Marcin Szczechowicz, Lukman Amanov, Arian Arjomandi Rad, Anja Osswald, Saeed Torabi, Arjang Ruhparwar, and Alexander Weymann. 2022. "Non-Inferiority of Sutureless Aortic Valve Replacement in the TAVR Era: David versus Goliath" Life 12, no. 7: 979. https://doi.org/10.3390/life12070979