Edge-to-Edge Repair for Tricuspid Valve Regurgitation. Preliminary Echo-Data and Clinical Implications from the Tricuspid Regurgitation IMAging (TRIMA) Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Population
2.2. Echocardiography
2.3. Procedure
2.4. Outcomes and Endpoints
2.5. Statistical Analysis
3. Results
3.1. Baseline Characteristics
3.2. Procedural and Echocardiographic Results
3.3. Clinical Outcomes
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Patient Characteristics | N = 13 |
---|---|
Mean age, years ± SD | 81 ± 4 |
Gender-female, n (%) | 11 (85) |
BSA, m2 ± SD | 1.7 ± 0.2 |
STS score, % median (Q1–Q3) | 5.8 (3.8–7.7) |
EuroScore II, % ± SD | 8 ± 4 |
Diabetes, n (%) | 4 (31) |
Hypertension, n (%) | 12 (92) |
Hyperlipidaemia, n (%) | 5 (38) |
Coronary artery disease, n (%) | 4 (31) |
Smoking, n (%) | 1 (8) |
Atrial fibrillation, n (%) | 13 (100) |
History of cerebrovascular insult, n (%) | 2 (15) |
COPD, n (%) | 2 (15) |
CIED, n (%) | 4 (31) |
Previous TAVI implantation, n (%) | 3 (23) |
NYHA functional class III or more, n (%) | 13 (100) |
Medications | |
Salicylic Acid, n (%) | 3 (23) |
Novel oral anticoagulant, n (%) | 8 (62) |
Warfarin, n (%) | 4 (31) |
Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, n (%) | 6 (46) |
Digoxin, n (%) | 3 (23) |
Calcium channel blocker, n (%) | 3 (23) |
Beta-blocker, n (%) | 11 (85) |
Diuretic, n (%) | 13 (100) |
Echocardiographic Parameter | Pre-TriClip | Post-TriClip | p Value |
---|---|---|---|
LVEF, % ± SD | 50 ± 7 | 49 ± 8 | 0.473 |
TAPSE, mm ± SD | 16 ± 3 | 17 ± 3 | 0.150 |
S’ wave, cm/s ± SD | 9.3 ± 2.4 | 9.5 ± 1.5 | 0.732 |
FAC, % ± SD | 33 ± 8 | 36 ± 8 | 0.370 |
PASP, mmHg ± SD | 43 ± 9.5 | 36.5 ± 9.1 | 0.034 |
TAPSE/PASP, mm/mmHg ± SD | 0.37 ± 0.1 | 0.46 ± 0.1 | 0.011 |
TR grade | |||
1 | 46% (6) | 0.001 | |
2 | 46% (6) | ||
3 | 69% (9) | ||
4 | 23% (3) | 8% (1) | |
5 | 8% (1) | ||
TR VC, mm ± SD | 8 ± 1 | 4 ± 2 | <0.001 |
TR EROA, cm2 ± SD | 0.63 ± 0.28 | 0.32 ± 0.21 | <0.001 |
TV mean diastolic gradient, mmHg ± SD | 0.9 ± 0.6 | 1.9 ± 1.1 | 0.004 |
TV V max, m/s ± SD | 2.8 ± 0.7 | 2.5 ± 0.5 | 0.105 |
TR volume, mL ± SD | 57 ± 16 | 28 ± 16 | <0.001 |
Tricuspid annulus diameter, mm ± SD | 44 ± 5 | 40 ± 4 | <0.001 |
RV length, mm ± SD | 60 ± 7 | 56 ± 6 | 0.08 |
RV middle diameter, mm ± SD | 42 ± 6 | 35 ± 6 | 0.003 |
RV basal diameter, mm ± SD | 47 ± 7 | 43 ± 4 | 0.001 |
RV end diastolic area, cm2 ± SD | 19 ± 4 | 16 ± 3 | 0.049 |
RA area, cm2 ± SD | 28 ± 8 | 26 ± 8 | 0.026 |
IVC, mm ± SD | 22 ± 3 | 18 ± 5 | 0.004 |
Adverse Events and Clinical Status (N, %) | 30-Day Follow-Up (N = 13) | 6-Month Follow-Up (N = 10) |
---|---|---|
Cardiovascular mortality | 0 | 0 |
Myocardial infarction | 0 | 0 |
Stroke | 0 | 0 |
New onset renal failure | 0 | 0 |
Nonelective surgery for tricuspid valve repair | 0 | 0 |
Endocarditis requiring surgery | 0 | 0 |
Major bleeding 1 | 0 | 0 |
New onset of liver failure | 0 | 0 |
Pulmonary thromboembolism | 0 | 0 |
Device embolisation | 0 | 0 |
Single leaflet device attachment | 1 (13%) | 0 |
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Carpenito, M.; Cammalleri, V.; Vitez, L.; De Filippis, A.; Nobile, E.; Bono, M.C.; Mega, S.; Bunc, M.; Grigioni, F.; Ussia, G.P. Edge-to-Edge Repair for Tricuspid Valve Regurgitation. Preliminary Echo-Data and Clinical Implications from the Tricuspid Regurgitation IMAging (TRIMA) Study. J. Clin. Med. 2022, 11, 5609. https://doi.org/10.3390/jcm11195609
Carpenito M, Cammalleri V, Vitez L, De Filippis A, Nobile E, Bono MC, Mega S, Bunc M, Grigioni F, Ussia GP. Edge-to-Edge Repair for Tricuspid Valve Regurgitation. Preliminary Echo-Data and Clinical Implications from the Tricuspid Regurgitation IMAging (TRIMA) Study. Journal of Clinical Medicine. 2022; 11(19):5609. https://doi.org/10.3390/jcm11195609
Chicago/Turabian StyleCarpenito, Myriam, Valeria Cammalleri, Luka Vitez, Aurelio De Filippis, Edoardo Nobile, Maria Caterina Bono, Simona Mega, Matjaz Bunc, Francesco Grigioni, and Gian Paolo Ussia. 2022. "Edge-to-Edge Repair for Tricuspid Valve Regurgitation. Preliminary Echo-Data and Clinical Implications from the Tricuspid Regurgitation IMAging (TRIMA) Study" Journal of Clinical Medicine 11, no. 19: 5609. https://doi.org/10.3390/jcm11195609
APA StyleCarpenito, M., Cammalleri, V., Vitez, L., De Filippis, A., Nobile, E., Bono, M. C., Mega, S., Bunc, M., Grigioni, F., & Ussia, G. P. (2022). Edge-to-Edge Repair for Tricuspid Valve Regurgitation. Preliminary Echo-Data and Clinical Implications from the Tricuspid Regurgitation IMAging (TRIMA) Study. Journal of Clinical Medicine, 11(19), 5609. https://doi.org/10.3390/jcm11195609