Professional Documents
Culture Documents
6, 2023
STRUCTURAL
Augustin Coisne, MD, PHD,a,b,c,* Andrea Scotti, MD,a,b,* Maurizio Taramasso, MD,d Juan F. Granada, MD,b
Sebastian Ludwig, MD,a,b,e Josep Rodés-Cabau, MD,f Philipp Lurz, MD, PHD,g Jörg Hausleiter, MD,h Neil Fam, MD,i
Susheel K. Kodali, MD,j Alberto Pozzoli, MD,k Hannes Alessandrini, MD,l Luigi Biasco, MD,m,n Eric Brochet, MD,o
Paolo Denti, MD,p Rodrigo Estevez-Loureiro, MD,q Christian Frerker, MD,r Edwin C. Ho, MD,a Vanessa Monivas, MD,s
Georg Nickenig, MD,t Fabien Praz, MD,u Rishi Puri, MD, PHD,v Horst Sievert, MD,w Gilbert H.L. Tang, MD, MSC, MBA,x
Martin Andreas, MD, PHD,y Ralph Stephan Von Bardeleben, MD,z Karl-Philipp Rommel, MD,g
Guillem Muntané-Carol, MD,f Mara Gavazzoni, MD,d Daniel Braun, MD,h Edith Lubos, MD,e Daniel Kalbacher, MD,e,aa
Kim A. Connelly, MD,i Jean-Michel Juliard, MD,o Claudia Harr, MD,l Giovanni Pedrazzini, MD,n,bb
François Philippon, MD,f Joachim Schofer, MD,l Holger Thiele, MD,g Matthias Unterhuber, MD,g
Dominique Himbert, MD,o Marina Ureña Alcázar, MD, PHD,o Mirjam G. Wild, MD,u Ulrich Jorde, MD,a
Stephan Windecker, MD,u Francesco Maisano, MD,p Martin B. Leon, MD,b,j Rebecca T. Hahn, MD,b,j Azeem Latib, MDa
ABSTRACT
BACKGROUND Data regarding the impact of the tricuspid valve gradient (TVG) after tricuspid transcatheter edge-to-
edge repair (TEER) are scarce.
OBJECTIVES This study sought to evaluate the association between the mean TVG and clinical outcomes among pa-
tients who underwent tricuspid TEER for significant tricuspid regurgitation.
METHODS Patients with significant tricuspid regurgitation who underwent tricuspid TEER within the TriValve (Inter-
national Multisite Transcatheter Tricuspid Valve Therapies) registry were divided into quartiles based on the mean TVG at
discharge. The primary endpoint was the composite of all-cause mortality and heart failure hospitalization. Outcomes
were assessed up to the 1-year follow-up.
RESULTS A total of 308 patients were included from 24 centers. Patients were divided into quartiles of the mean TVG
as follows: quartile 1 (n ¼ 77), 0.9 0.3 mm Hg; quartile 2 (n ¼ 115), 1.8 0.3 mm Hg; quartile 3 (n ¼ 65), 2.8
0.3 mm Hg; and quartile 4 (n ¼ 51), 4.7 2.0 mm Hg. The baseline TVG and the number of implanted clips were
associated with a higher post-TEER TVG. There was no significant difference across TVG quartiles in the 1-year composite
endpoint (quartiles 1-4: 35%, 30%, 40%, and 34%, respectively; P ¼ 0.60) or the proportion of patients in New York
Heart Association class III to IV at the last follow-up (P ¼ 0.63). The results were similar after adjustment for clinical and
echocardiographic characteristics (composite endpoint quartile 4 vs quartile 1-quartile 3 adjusted HR: 1.05; 95% CI: 0.52-
2.12; P ¼ 0.88) or exploring post-TEER TVG as a continuous variable.
CONCLUSIONS In this retrospective analysis of the TriValve registry, an increased discharge TVG was not significantly
associated with adverse outcomes after tricuspid TEER. These findings apply for the explored TVG range and up to the
1-year follow-up. Further investigations on higher gradients and longer follow-up are needed to better guide the
intraprocedural decision-making process. (J Am Coll Cardiol Intv 2023;16:706–717) © 2023 Published by Elsevier on
behalf of the American College of Cardiology Foundation.
T ricuspid regurgitation (TR) is a highly preva- TriValve (International Multisite Trans- ABBREVIATIONS
lent valvular heart disease and is associated catheter Tricuspid Valve Therapies; AND ACRONYMS
1-3
with adverse long-term clinical outcomes. NCT03416166) registry.
HF = heart failure
In light of the rarely performed isolated surgery,4,5
transcatheter tricuspid valve intervention (TTVI) has METHODS MR = mitral regurgitation
Q = quartile
emerged as a safe and effective therapeutic option
for selected patients with symptomatic TR and high STUDY POPULATION. The details of the Tri- ROC = receiver-operating
From the aMontefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medi-
cine, Bronx, New York, USA; bCardiovascular Research Foundation, New York, New York, USA; cUniversitè Lille, Inserm, CHU
Lille, Institut Pasteur de Lille, U1011–EGID, Lille, France; dHeart Center Hirslanden Zürich, Zürich, Switzerland; eDepartment of
Cardiology, University Heart and Vascular Center, Hamburg, Germany; fQuebec Heart and Lung Institute, Laval University,
Quebec City, Quebec, Canada; gHeart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany;
h
Medical Clinic and Polyclinic I, University Hospital of Munich, Munich, Germany; iDivision of Cardiology, Toronto Heart Center,
St. Michael’s Hospital, Toronto, Ontario, Canada; jDivision of Cardiology, Columbia University Medical Center-NewYork Presby-
terian Hospital, New York, New York, USA; kDivision of Cardiac Surgery, Cardiocentro Ticino Institute, Ente Ospedaliero Canto-
nale, Lugano, Switzerland; lAsklepios Clinic St. Georg, Hamburg, Germany; m
Azienda Sanitaria Locale Torino 4, Ciriè, Italy;
n
Department of Biomedical Sciences, University of Italian Switzerland, Lugano, Switzerland; oDivision of Cardiology, Bichat
Hospital, Paris, France; pDivision of Cardiology and Department of Cardiac Surgery, San Raffaele University Hospital, Milan, Italy;
q
Interventional Cardiology Clinic, University Hospital Alvaro Cunqueiro, Vigo, Spain; rUniversity Heart Center, Schleswig-Holstein
University, Lübeck, Germany; sDivision of Cardiology, Puerta de Hierro University Hospital, Madrid, Spain; tDivision of Cardiol-
ogy, Bonn University Hospital, Bonn, Germany; uDivision of Cardiology, Inselspital, Bern University Hospital, Bern, Switzerland;
v
Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio, USA; wDivision of Cardiology, Cardio-
vascular Center Frankfurt, Frankfurt am Main, Germany; xDepartment of Cardiovascular Surgery, Mount Sinai Health System,
New York, New York, USA; yDepartment of Cardiac Surgery, Medical University of Vienna, Vienna, Austria; zDivision of Cardi-
ology, University Medical Center, Mainz, Germany; aaGerman Center for Cardiovascular Research, Partner Site Hamburg/Luebeck/
bb
Kiel, Germany; and the Division of Cardiology, Istituto Cardiocentro Ticino, Ente Ospedaliero Cantonale, Lugano, Switzerland.
*Drs Coisne and Scotti contributed equally to this work and are co-first authors.
Thomas Modine, MD, served as Guest Editor for this paper. Lars Søndergaard, MD, served as Guest Editor-in-Chief for this paper.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’
institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information,
visit the Author Center.
Manuscript received October 24, 2022; revised manuscript received January 24, 2023, accepted January 26, 2023.
708 Coisne et al JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023
6
Tricuspid Valve Gradient (mm Hg)
2 4.7
2.8
1 1.8
0.9
0
Q1 Q2 Q3 Q4
(n = 77) (n = 115) (n = 65) (n = 51)
B Death or HF Hospitalization
100%
or HF Hospitalization
Freedom From Death
75% 70%
66%
65%
60%
50%
25%
(A) The mean (SD) of post–transcatheter edge-to-edge repair (TEER) tricuspid valve gradient (TVG). (B) Kaplan-Meier analysis of 1-year
freedom from death or heart failure (HF) hospitalization showing no difference across quartiles of post-TEER TVG. Q ¼ quartile.
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023 Coisne et al 709
MARCH 27, 2023:706–717 Impact of Tricuspid Valve Gradient After TEER
Age, y 76.4 9.2 77.8 9.0 76.5 9.2 76.0 9.6 74.9 9.2 0.48
Men 136 (44.2) 35 (45.5) 54 (47.0) 27 (41.5) 20 (39.2) 0.78
BMI, kg/m2 26.1 4.9 26.1 4.2 25.7 4.5 27.2 5.8 25.4 5.8 0.37
Diabetes 85 (27.7) 19 (24.7) 29 (25.4) 23 (35.4) 14 (27.5) 0.46
COPD 71 (23.1) 18 (23.4) 20 (17.4) 17 (26.2) 16 (31.4) 0.22
Atrial fibrillation 189 (61.8) 49 (64.5) 67 (58.8) 42 (64.6) 31 (60.8) 0.82
Prior MI 49 (15.9) 16 (20.8) 21 (18.3) 7 (10.8) 5 (9.8) 0.21
PM/ICD 87 (28.3) 23 (30.3) 25 (21.7) 22 (33.8) 17 (33.3) 0.24
Ascites 63 (22.3) 9 (13.2) 26 (23.6) 15 (25.4) 13 (28.9) 0.19
Peripheral edema 207 (72.9) 42 (60.9) 85 (77.3) 44 (74.6) 36 (78.3) 0.08
Previous RV failure 185 (68.2) 43 (64.2) 76 (80.0) 37 (67.3) 29 (69.1) 0.11
Previous left-side valve intervention 68 (22.1) 13 (16.9) 18 (15.7) 18 (27.7) 19 (37.3) <0.01
NYHA functional class III-IV 277 (91.1) 67 (87.0) 107 (93.0) 56 (91.8) 47 (92.2) 0.53
TR etiology 0.14
Functional 266 (86.9) 63 (82.9) 101 (87.8) 58 (89.2) 44 (88.0)
Degenerative 15 (4.9) 7 (9.2) 4 (3.5) 2 (3.1) 2 (4.0)
Mixed 20 (6.5) 5 (6.6) 9 (7.8) 5 (7.7) 1 (2.0)
Other 5 (1.6) 1 (1.3) 1 (0.9) 0 (0.0) 3 (6.0)
EuroSCORE II, % 6.1 (3.7-10.4) 5.8 (3.1-13.2) 5.9 (3.6-10.8) 6.1 (4.2-9.6) 6.2 (3.8-9.3) 0.94
STS mortality, % 4.0 (2.6-6.6) 4.5 (2.4-7.4) 3.9 (2.6-6.5) 4.3 (2.7-66) 4.0 (2.4-6.0) 0.89
Hemoglobin, g/dL 10.3 2.4 10.5 2.5 10.3 2.4 10.0 2.5 10.5 2.4 0.63
eGFR, mL/min/1.73 m2 47.1 19.7 47.7 18.4 45.4 20.0 48.4 20.1 48.6 20.4 0.68
NT-proBNP, pg/mL 2,760 (1,502-5,702) 3,037 (1,550-6,454) 3,089 (1,649-5,780) 2,550 (1,373-4,891) 2,107 (1,108-4,313) 0.31
AST, U/L 28.0 (22.0-35.0) 28.2 (22.5-36.9) 28.4 (22.2-35.6) 26.4 (20.7-33.0) 27.0 (23.0-37.4) 0.79
ALT, U/L 19.8 (14.9-26.0) 19.8 (16.0-28.6) 21.0 (14.0-28.0) 17.4 (14.0-23.2) 19.0 (14.3-24.8) 0.27
GGT, U/L 94.0 (54.0-167.5) 87.0 (47.7-128.0) 96.3 (56.0-173.8) 95.7 (52.5-155.5) 110.0 (74.0-230.5) 0.11
Beta-blockers 264 (86.3) 72 (93.5) 97 (84.3) 57 (89.1) 38 (76.0) 0.03
Anti-RAAS 210 (70.2) 52 (67.5) 72 (65.5) 51 (81.0) 35 (71.4) 0.17
Aldosterone antagonists 135 (44.1) 27 (35.1) 56 (48.7) 27 (42.2) 25 (50.0) 0.23
was in atrial fibrillation), and the average was re- were collected at discharge, at 30 days, and then ac-
ported. TR severity was graded into 4 grades (ie, mild cording to the time frame elapsed from the index
[1þ], moderate [2þ], severe [3þ], and massive/ procedure to data lock for the present analysis.
torrential [4þ]) using a combination of semi- Follow-up clinical events and echocardiographic data
quantitative and quantitative assessment as were collected by each local investigator and pro-
described by the American Society of Echocardiogra- vided to the international data coordinating center.
phy guidelines and the European Association of
STATISTICAL ANALYSIS. Categoric variables were
Echocardiography guidelines. 17-19 Procedural success
reported as numbers and corresponding proportions
was defined as the patient alive at the end of the
and compared with the chi-square test with conti-
procedure with the device successfully implanted and
nuity correction or the Fisher exact test as appro-
the delivery system retrieved with a residual TR #2þ.
priate. Continuous variables were described as mean
CLINICAL OUTCOMES. The primary endpoint was SD or median (IQR) and compared with 1-way
mortality from any cause or HF hospitalization. The analysis of variance (parametric test) or the Kruskal-
secondary endpoints were overall mortality, HF hos- Wallis test (nonparametric test) according to their
pitalization, and functional class. Follow-up data distribution. The cumulative survival and freedom
710 Coisne et al JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023
LVEF, % (n ¼ 305) 49.8 13.9 48.0 15.5 49.1 13.0 51.0 14.2 52.6 12.4 0.24
LVEDD, mm (n ¼ 297) 50.9 9.2 52.1 9.5 50.4 8.8 51.0 9.5 50.3 9.3 0.62
Left atrial volume, mL (n ¼ 258) 102.5 46.4 102.7 41.8 98.2 44.6 111.9 49.9 99.4 52.8 0.34
TVG, mm Hg (n ¼ 273) 1.2 0.6 1.1 0.4 1.2 0.5 1.3 0.7 1.7 0.9 <0.001
TR severity (n ¼ 308) 0.02
2/4 11 (3.6) 6 (7.9) 4 (3.5) 1 (1.5) 0 (0.0)
3/4 142 (46.3) 38 (50.0) 58 (50.4) 30 (46.2) 16 (31.4)
4/4 154 (50.2) 32 (42.1) 53 (46.1) 34 (52.3) 35 (68.6)
Concomitant MR $3þ (n ¼ 308) 126 (40.9) 33 (42.9) 54 (47.0) 22 (33.8) 17 (33.3) 0.22
TR jet location (n ¼ 308) 0.36
Central 187 (60.7) 45 (58.4) 76 (66.1) 40 (61.5) 26 (51.0)
Anteroseptal 45 (14.6) 13 (16.9) 16 (13.9) 11 (16.9) 5 (9.8)
Anteroposterior 6 (1.9) 3 (3.9) 1 (0.9) 1 (1.5) 1 (2.0)
Posteroseptal 17 (5.5) 3 (3.9) 8 (7.0) 2 (3.1) 4 (7.8)
Unknown 53 (17.2) 13 (16.9) 14 (12.2) 11 (16.9) 15 (29.4)
TR vena contracta, cm (n ¼ 266) 0.99 0.38 0.93 0.36 0.94 0.31 1.05 0.40 1.14 0.46 0.01
TR RV, mL (n ¼ 149) 48.5 27.1 44.5 23.9 48.0 22.1 48.7 35.1 58.6 32.3 0.34
TR EROA, cm2 (n ¼ 247) 0.64 0.52 0.56 þ 0.49 0.69 0.55 0.66 0.57 0.66 0.44 0.50
TV annulus diameter, mm (n ¼ 262) 46.8 7.5 48.2 7.3 46.6 7.8 46.5 6.6 45.3 8.2 0.27
Tricuspid coaptation depth, mm (n ¼ 194) 9.0 3.7 9.5 4.2 8.7 3.3 9.0 3.3 9.1 4.3 0.64
Tricuspid tenting area, cm2 (n ¼ 192) 2.2 1.3 2.5 1.8 2.1 1.1 2.1 1.1 2.1 1.2 0.35
RVEDD, mm (n ¼ 135) 40.3 12.7 38.9 11.1 41.5 14.2 40.8 10.1 39.1 15.0 0.77
Right atrial volume, mL (n ¼ 194) 101.6 53.9 95.3 50.0 101.4 52.5 114.0 66.9 94.1 38.5 0.35
TAPSE, mm (n ¼ 277) 16.7 5.1 18.0 6.5 16.9 4.6 15.7 4.5 16.8 4.3 0.10
SPAP, mm Hg (n ¼ 144) 41 15.8 40.6 15.3 41.6 15.7 40.6 15.9 40.7 17.5 0.97
Procedure
Duration of procedure, min 122.9 52.1 114.8 45.3 114.9 39.9 140.4 70.8 135.5 57.3 0.01
Concomitant mitral or aortic intervention 102 (43.2) 22 (36.7) 41 (47.1) 22 (42.3) 17 (45.9) 0.63
Number of tricuspid clips implanted 0.32
1 16 (5.3) 7 (9.2) 4 (3.5) 3 (4.7) 2 (4.2)
2 70 (23.1) 18 (23.7) 30 (26.1) 11 (17.2) 11 (22.9)
3 144 (47.5) 37 (48.7) 57 (49.6) 30 (46.9) 20 (41.7)
4 65 (21.5) 12 (15.8) 24 (20.9) 17 (26.6) 12 (25.0)
$5 8 (2.6) 2 (2.6) 0 (0.0) 3 (4.7) 3 (6.2)
Number of tricuspid clips implanted 1.9 0.9 1.8 0.9 1.9 0.8 2.1 0.9 2.1 1.0 0.11
Postprocedural echocardiography
TR severity 0.14
0/4 6 (2.0) 1 (1.3) 3 (2.6) 2 (3.1) 0 (0.0)
1/4 136 (44.6) 42 (55.3) 50 (43.9) 26 (40.0) 18 (36.0)
2/4 114 (37.4) 25 (32.9) 49 (43.0) 22 (33.8) 18 (36.0)
3/4 39 (12.8) 6 (7.9) 9 (7.9) 13 (20.0) 11 (22.0)
4/4 10 (3.3) 2 (2.6) 3 (2.6) 2 (3.1) 3 (6.0)
Delta TR severity (post- vs pre-TR severity) 0.53
0 22 (7.2) 3 (4.0) 7 (6.1) 7 (10.8) 5 (10.0)
1 92 (30.3) 27 (36.0) 32 (28.1) 17 (26.2) 16 (32.0)
2 130 (42.8) 28 (37.3) 54 (47.4) 30 (46.2) 18 (36.0)
3 59 (19.4) 17 (22.7) 21 (18.4) 10 (15.4) 11 (22.0)
4 1 (0.3) 0 (0.0) 0 (0.0) 1 (1.5) 0 (0.0)
Tricuspid valve gradient, mm Hg 2.3 1.5 0.9 0.3 1.8 0.3 2.8 0.3 4.7 2.0 <0.01
Delta TVG, mm Hg 1.10 1.14 0.06 0.19 0.74 0.47 1.52 0.66 2.93 1.13 <0.01
TV annulus diameter, mm 44.6 7.6 46.2 7.0 43.9 7.2 43.6 8.3 45.1 8.4 0.34
LVEF, % 49.8 14.1 48.6 15.8 50.0 13.4 49.8 14.1 51.2 13.0 0.78
TAPSE, mm 16.0 4.5 17.0 4.8 15.9 4.4 15.6 4.6 15.4 3.9 0.26
SPAP, mm Hg 38.7 12.7 38.0 13.4 38.9 12.2 38.1 12.9 39.8 12.8 0.87
Postprocedural outcomes
AKI 30 (12.2) 8 (12.9) 13 (13.7) 7 (13.7) 2 (5.4) 0.59
New-onset atrial fibrillation 4 (1.6) 0 (0.0) 2 (2.0) 0 (0.0) 2 (5.4) 0.15
Length of stay, d 4.0 (2.0-6.0) 3.0 (2.0-5.0) 4.0 (2.0-6.0) 4.0 (3.0-5.0) 3.0 (2.0-7.0) 0.55
Conversion to surgery 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) NA
In-hospital all-cause mortality 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) NA
Echocardiographic variables are shown in Table 2. success rate (Q1 ¼ 89.5%, Q2 ¼ 86.8%, Q3 ¼ 76.9%,
No differences were observed in terms of left ven- and Q4 ¼ 72%; P ¼ 0.02). The overall length of stay
tricular ejection fraction, left and right ventricular was 4.0 days (IQR: 2.0-6.0 days) with no in-hospital
end-diastolic diameters, left and right atrial volumes, mortality. Analyses stratifying the population per
and systolic pulmonary artery pressure. Preoperative post-TEER TVG median are provided in Supplemental
TR grading and severity, as assessed by vena con- Tables 1 to 3 and showed similar results compared
tracta width, were higher in Q4 (P ¼ 0.01 and P ¼ 0.02, with the quartile distribution. Finally, there were no
respectively). Most patients (n ¼ 217, 71.6%) were differences between the mean TVG post-TEER and
implanted with $3 clips with no differences among Q1 those at the last TTE follow-up (n ¼ 90, 2.16 1.28 vs
to Q4 (P ¼ 0.32) (Table 3), and all groups obtained a 2.28 1.22, respectively; P ¼ 0.26).
similar benefit in terms of postprocedural TR
(P ¼ 0.32). Patients in Q4 had higher frequencies of ASSOCIATION BETWEEN TVG QUARTILES AND
residual TR $3þ (Q1 ¼ 10.5%, Q2 ¼ 10.5%, Q3 ¼ 23.1%, CLINICAL OUTCOMES. The median (Q1-Q3) duration
and Q4 ¼ 28.0%; P < 0.01) and a lower procedural of follow-up was 174 days (IQR: 43-364 days).
712 Coisne et al JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023
There was no difference in 1-year freedom from (left) death or (right) heart failure (HF) hospitalization among the 4 quartiles of post– transcatheter edge-to-edge
repair (TEER) tricuspid valve gradient (TVG) distribution.
F I G U R E 2 Changes in NYHA Functional Class From Baseline to Last Follow-Up by Post–Transcatheter Edge-to-Edge Repair TVG Quartiles
No significant differences in New York Heart Association (NYHA) functional class III/IV were observed between tricuspid valve gradient (TVG)
quartile (Q) 4 and TVG Q1 to Q3 at each time point. *Comparison for NYHA functional class III/IV.
hospitalization (P ¼ 0.75). Finally, there was no dif- After multivariable adjustment, the baseline TVG
ference between patients in Q4 and patients in Q1 to (P ¼ 0.0001) and the number of implanted clips
Q3 regarding New York Heart Association functional (P ¼ 0.004) were independently associated with a
class III to IV before TEER (P ¼ 0.78), at 30 days higher TVG post-TEER (Supplemental Table 6).
(P ¼ 0.84), and at the last follow-up (P ¼ 0.63) No association was observed for baseline or residual
(Figure 2, Supplemental Figure 1). TR.
IMPACT AND PREDICTORS OF INCREASED TVG AS A SUBGROUP ANALYSIS. To further explore the asso-
CONTINUOUS VARIABLE. We used restricted cubic ciation between post-TEER TVG and residual TR with
spline regression analyses to assess whether there clinical outcomes, patients were classified into 4
was a nonlinear relationship between TVG measured groups based on discharge TVG quartiles and residual
on discharge echocardiography as a continuous vari- TR severity as follows: group 1, TVG Q1 to Q3 and
able and clinical outcomes. No nonlinear associations TR #2þ (n ¼ 220); group 2, TVG Q4 and TR #2þ (n ¼ 36);
were found for every investigated endpoint (all group 3, TVG Q1 to Q3 and TR >2þ (n ¼ 35); and group 4,
P > 0.05) (Figure 3). In addition, a ROC curve for TVG Q4 and TR >2þ (n ¼ 14). There was no difference in
prediction of the composite endpoint at 1 year was outcomes between groups 1 and 2 (HR: 0.71; 95% CI:
performed. The ROC curve did not show any predic- 0.28-1.80; P ¼ 0.47), groups 3 and 4 (HR: 1.34; 95% CI:
tive capacity of the post-TEER TVG for all-cause 0.47-3.88; P ¼ 0.58), and groups 1 and 3 (HR: 1.58;
mortality or HF hospitalization (ROC AUC: 0.52; 95% CI: 0.77-3.27; P ¼ 0.21). There was a trend for an
95% CI: 0.44-0.60; P ¼ 0.52) (Supplemental Figure 2). increased risk of death or HF hospitalization between
714 Coisne et al JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023
DISCUSSION
mitral valve may not be valid for the tricuspid valve after tricuspid TEER. Future studies are needed to
(TV). Indeed, the TV, which is composed of 3 or more assess whether any difference may emerge with
leaflets,23 is larger than the mitral valve, 24-26 espe- higher TV gradients not observed in this registry or at
cially in atrial fibrillation patients, 27 who represent longer-term follow-up.
most of the patients with significant secondary TR. STUDY LIMITATIONS. The most relevant limitations
The TV is also subject to a lower pressure; therefore, of this study are inherent in its nonrandomized,
the inflow velocities and gradients across the TV are observational design; therefore, our results have to be
lower than across the mitral valve. considered as hypotheses generating. Because of the
Data regarding the impact of the TVG after surgical retrospective nature of this study, some parameters
TV repair or replacement are scarce. Normal bio- of tricuspid valve stenosis were not routinely
prosthetic mean gradients across a wide variety of assessed (ie, the tricuspid valve orifice area, peak
biological prostheses range between <6 to 9 mm Hg.28 velocity, or Doppler velocity index). Even if the
For TV repair, transvalvular gradients may be lower. evaluation of tricuspid stenosis usually requires the
In 71 patients who underwent prophylactic tricuspid integration of several echocardiographic and clinical
annuloplasty with a flexible ring, Shim et al29 found parameters (eg, heart rate), the assessment of TVG
that the TVG was low after surgery (1.65 solely based on Doppler analysis is reproducible and
0.74 mm Hg) and remained stable over a 5-year easy to acquire in daily practice. We acknowledge the
follow-up. In 419 patients who underwent concomi- relatively small sample size of the population, espe-
tant tricuspid annuloplasty for moderate TR and/or cially with high TVG, the short duration of follow-up,
tricuspid annular dilatation during mitral valve and the lack of echocardiographic core laboratory and
repair, Chikwe et al 30 found that the mean post- independent clinical events adjudication. Although
operative TVG was 2 mm Hg. To date, there is no clear our conclusions must be explored in randomized tri-
evidence on the impact of the postoperative TVG on als, these data contain the most comprehensive in-
TV biological prosthesis dysfunction or clinical out- formation on elevated TVGs and prognosis in patients
comes after TV surgery.28 undergoing tricuspid TEER so far. Finally, we
Although there is no generally accepted grading of acknowledge that the TVG at discharge may be
tricuspid stenosis severity, a mean echocardiographic different from the TVG in the operating room because
TVG $5 mm Hg defines significant native valvular of changes in loading conditions and heart rate under
tricuspid stenosis in international guidelines.31,32 The general anesthesia.
definition of significant bioprosthetic TV stenosis in
the VIVID (Valve-in-Valve International Database)
registry was a mean gradient $10 mm Hg empirically CONCLUSIONS
derived by the baseline hemodynamics of that patient
population.33 In the first study on tricuspid TEER, an In this retrospective analysis of the TriValve registry,
“acceptable” gradient after clipping was arbitrarily an increased TVG at discharge was not significantly
defined as a TVG #3 mm Hg. 20 Based on that arbitrary associated with adverse outcomes after tricuspid
expert definition, Orban et al 15 showed that patients TEER. These findings apply to the explored TVG
with a TVG >3 mm Hg at discharge had the same range and up to the 1-year follow-up. Further in-
midterm outcomes as patients with a TVG #3 mm Hg vestigations on higher gradients and longer follow-up
in a single-center study of 145 patients. Our study are needed to better guide the intraprocedural
strated that after adjustment for confounding risk sciences. Dr Lurz has received speaker fees from Abbott. Dr Hausleiter
has received speaker honoraria from Abbott Vascular and Edwards
factors, a higher postprocedural TVG was not inde-
Lifesciences. Dr Kodali has served on the scientific advisory board for
pendently associated with the occurrence of the pri- Microinterventional Devices, Dura Biotech, Thubrikar Aortic Valve,
mary and secondary endpoints at the 1-year follow-up and Supira; has served as a consultant for Meril Lifesciences,
716 Coisne et al JACC: CARDIOVASCULAR INTERVENTIONS VOL. 16, NO. 6, 2023
Admedus, Medtronic, and Boston Scientific; has served on the consultant for and received consulting fees and honoraria from
steering committee for Edwards Lifesciences and Abbott Vascular; Abbott Vascular, Edwards Lifesciences, Cardiovalve, SwissVortex,
has received honoraria from Meril Lifesciences, Admedus, Abbott Perifect, Xeltis, Transseptal Solutions, Magenta, Valtech, and Med-
Vascular, and Dura Biotech; and owns equity in Dura Biotech, Thu- tronic; has reported being a cofounder of 4Tech; has received
brikar Aortic Valve, Supira, and MID. Dr Alessandrini has received research grant support from Abbott, Medtronic, Edwards Life-
consulting fees from Abbott and Edwards LifeSciences. Dr Brochet sciences, Biotronik, Boston Scientific, NVT, and Terumo; has received
has received speaker fees from Abbott Vascular. Dr Denti has served royalties and owns intellectual property rights from Edwards Life-
as a consultant for Abbott Vascular, 4Tech, Neovasc, and InnovHeart; sciences (FMR surgical annuloplasty); and has reported being a
and has received honoraria from Abbott and Edwards Lifesciences. Dr shareholder in Cardiovalve, Swiss Vortex, Magenta, Transseptal So-
Estévez- Loureiro has received speaker fees from Abbott, Boston, and lutions, Occlufit, 4Tech, and Perifect. Dr Leon has received institu-
Edwards Lifesciences. Dr Ho has served as a consultant for NeoChord tional clinical research grants from Abbott, Boston Scientific, Edwards
Inc; and has received consulting fees from NeoChord Inc. Dr Praz has Lifesciences, and Medtronic. Dr Hahn has served as a consultant for
received travel expenses from Edwards Lifesciences, Abbott Vascular, Abbott Vascular, Abbott Structural, NaviGate, Philips Healthcare,
and Polares Medical. Dr Sievert has received study honoraria, travel Medtronic, Edwards Lifesciences, and GE Healthcare; has been the
expenses, and consulting fees from 4Tech Cardio, Abbott, Ablative Chief Scientific Officer for the Echocardiography Core Laboratory at
Solutions, Ancora Heart, Bavaria Medizin Technologie, Bioventrix, the Cardiovascular Research Foundation for multiple industry-
Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed BV, supported trials, for which she receives no direct industry compen-
Contego, CVRx, Edwards Lifesciences, Endologix, Hemoteq, Lifetech, sation; has received speaker fees from Boston Scientific and Baylis
Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Medical; and has received nonfinancial support from 3mensio. Dr
Occlutech, PFM Medical, ReCor, Renal Guard, Rox Medical, Terumo, Latib has served on the advisory board for Medtronic, Abbott Vascular
Vascular Dynamics, and Vivasure Medical. Dr Tang has served as a Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord Inc, V-
consultant, physician advisory board member, and faculty trainer for dyne, and Philips. All other authors have reported that they have no
Abbott Structural Heart; has served as a consultant for Medtronic and relationships relevant to the contents of this paper to disclose.
NeoChord; and has served as a physician advisory board member for
JenaValve. Dr Andreas has served as a proctor/consultant for and has
ADDRESS FOR CORRESPONDENCE: Dr Azeem Latib,
received speaker fees from Abbott, Edwards LifeSciences, Boston,
Zoll and Medtronic; and has received institutional grants from Section Head, Interventional Cardiology, Montefiore
Edwards Lifesciences, Abbott, Medtronic, and LSI Solutions. Dr Medical Center/Albert Einstein College of Medicine,
Gavazzoni has served as a consultant for Abbott Vascular. Dr Braun
1825 Eastchester Road, Bronx, New York 10461, USA.
has received speaker honoraria and travel support from Abbott
E-mail: alatib@gmail.com.
Vascular. Dr Lubos has received grant support and lecture fees from
Abbott; and has received lecture fees from Edwards Lifesciences. Dr
Kalbacher has received lecture fees from Abbott and Edwards Life-
PERSPECTIVES
sciences. Dr Connelly has received honoraria from Abbott. Dr Schofer
has served as a consultant for Edwards Lifesciences. Dr Windecker
reports research, travel, or educational grants to the institution from WHAT IS KNOWN? The balance between reaching
Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer
an optimal TR reduction and risking an iatrogenic
Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health,
CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, tricuspid stenosis is a central issue in any tricuspid
Edwards Lifesciences, Guerbet, InfraRedx, Janssen-Cilag, Johnson & TEER procedure.
Johnson, Medicure, Medtronic, Merck Sharp & Dohme, Miracor
Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer,
WHAT IS NEW? Among patients with significant TR,
Polares, Regeneron, Aventis, Servier, Sinomed, Terumo, Vifor, and V-
Wave. Dr Windecker serves as an unpaid advisory board member
higher TVGs on discharge echocardiography were not
and/or unpaid member of the steering/executive group of trials fun- significantly associated with adverse outcomes up to 1
ded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scien- year after tricuspid TEER.
tific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen,
MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Ter-
WHAT IS NEXT? Further investigations on higher
umo, V-Wave, and Xeltis, but has not received personal payments by
pharmaceutical companies or device manufacturers. He is also a gradients and longer follow-up are needed to better
member of the steering/executive committee group of several guide the intraprocedural decision-making process.
investigator-initiated trials that receive funding by industry without
impact on his personal remuneration. Dr Maisano has served as a
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